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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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polarcup dual mobility system SMITH & NEPHEW, INC. k122244 08/23/2012
podiatry x-ray system SOURCE-RAY, INC. k133959 01/22/2015
pleurofix thoracentesis kit BURRON MEDICAL PRODUCTS, INC. k820004 02/04/1982
playtex (scented and unscented) sport fresh balance tampons PLAYTEX MANUFACTURING INC. k132819 10/09/2013
plato 17 microcatheter Scientia Vascular Inc k223560 08/21/2023
platelia lyme igg assay BIO-RAD k080012 05/08/2008
plastic fracture cast brace knee joint ORTHOMEDICS k802910 12/22/1980
plastic finger cuffs FRED SAMMONS, INC. k761134 12/02/1976
planet 55, model 100 LARSEN & TOUBRO LIMITED k090443 06/05/2009
plain and chronic gut absorbable surgical sutures, usp ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. k000542 04/28/2000

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