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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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pico single use negative pressure wound therapy system Smith & Nephew Medical Limited k180614 04/06/2018
phipiological synchronizer part#205 BRATTLE INSTRUMENT CORP. k781681 10/17/1978
phasix st mesh with open positioning system C.R. Bard, Inc. k190185 06/12/2019
pharaon lipo OSYRIS k073617 04/09/2008
peri-guard repair patch, supple peri-guard repair patch Synovis Life Technologies, Inc. k221029 10/19/2022
percutaneous transhepatic cholang. tray AMERICAN PHARMASEAL DIV. AHSC k813335 01/08/1982
percutaneous cricothyroidotomy FREDERIC J. TOYE, M.D. k822440 10/15/1984
pentex bronchofiberscope model fb-17a PENTAX PRECISION INSTRUMENT CORP. k792267 12/19/1979
panbio indx igm dip-s-ticks leptospirosis test for the detection of igm antibodies to leptospira biflexa PANBIO, INC. k002024 11/22/2000
palomar lux1540 handpiece PALOMAR MEDICAL PRODUCTS, INC. k061652 02/27/2007

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