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Page 1 of 3 510(k) Summary - Food and Drug …

Shanghai, P.R.China Contact: Maggie Zhong Tel:+86-21-33907930 Fax:+8621-33907932 Mail: Date of Summnary: Jan 11th, 2009 2. Device Name: DS6 N95 Surgical Masks and flat surgical masks 3. Classification Maine: Surgical N95 Mask and flat surgical mask 4.. Device Description The DS DTC3M.-1 N95 surgical mask is constructed from a polypropylene

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510K Summary - Food and Drug Administration

510(k) for ASTM F2100 Level 2 and Level 3 Face Mask(s) OC 202011o 510K Summary Date Summary was May 17, 2011 Prepared: 610(k) Submitter: Ann Waterhouse, RAC Associate Director of Regulatory Affairs Roswell, GA 30076 678-352-671 9 (telephone) 920-225-3108 (facsimile) Ann.waterhouse(&kcc Device Trade Name: KG 200 Face Mask KG 300 Face Mask

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N95 Respirators and Surgical Masks (Face Masks) | FDA

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510(k) SUBSTANTIAL EQUIVALENCE ... - accessdata.fda.gov

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K132508 B. Purpose for Submission: The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (K111507, K123905, and K130551) has been modified with the …

Coronavirus Disease 2019 (COVID-19) | FDA

FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) pandemic.

September 2019 510(K) Clearances | FDA

510(k) NO: K192011(Abbreviated) ATTN: Mª Luisa Gomez de Aguero PHONE NO : 34 91 6280544 C/Pelaya, 9 -13 Pol. Ind. Rio de JSE DECISION MADE: 25-SEP-19 Algete ES 28110 510(k) SUMMARY AVAILABLE FROM ...

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confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

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510(k) Program Pilots | FDA

Note: If the 510(k) is found to be ineligible for the Quality in 510(k) Review Program pilot, the FDA will email the official contact of the 510(k) to inform them of this decision and the reason ...

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Guidance for Industry and FDA Staff . Surgical Masks - Premarket Notification [510(k)] Submissions . Document issued on: March 5, 2004 and a correction posted on July 14, 2004.

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Submitter's Identification: DEC 2 1 2012

Premrarket Notification -510(k) Submission -K122717 Tiger Medical -SUMMARY 510(K) Summary 7 - This summary of 510(K) is being submitted in accordance with the requirements of 21 CFR 807.92. 1. Submitter's Identification: DEC 2 1 2012 Tiger Medical Products Ltd.

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