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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 ...

May 2019 510(K) Clearances | FDA 510(k) NO: K181854(Traditional) ATTN: Jungmin Yoo PHONE NO : 82 51 8502500 66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 07-MAY-19 Busan KR 612-070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE ...

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[PDF]510K Summary - Food and Drug Administration 510K Summary. 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.com Device Trade Name: KG 200 Face Mask KG 300 Face Mask …

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N95 Respirators and Surgical Masks (Face Masks) | FDA N95 respirators and surgical masks (face masks) are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face.

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[PDF]Paul Dryden Consultant - accessdata.fda.gov U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.15 Silver Spring, MD 20993 www.fda.gov May 26, 2020 Hill-Rom Services Pte Ltd Paul Dryden Consultant 1 Yishun Ave 7 Singapore 768923 Singapore Re: K200988 Trade/Device Name: Maximus System Regulation Number: 21 CFR 868.5905

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