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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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silastic brand percutaneous skin expande DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS k801042 06/26/1980
silastic voice prosthesis DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS k812864 11/24/1981
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
single use balloon dilator v (with knife) Olympus Medical Systems Corp. k193039 12/17/2019
single-patient use disposable sensor series NONIN MEDICAL, INC. k093853 06/04/2010
single-use latex sterile surgical gloves (sg100) Fitone Latex Products Co., Ltd. Guangdong k231446 09/22/2023
skintact radiotransparent multifunction electrodes LEONHARD LANG GMBH k103186 02/08/2011
sleepright prorx custom dental guard Splintek, Inc. k193577 06/01/2020
smartspot primax CMT MEDICAL TECHNOLOGIES, LTD. k080890 04/29/2008
smith & nephew healicoil pk suture anchor SMITH & NEPHEW, INC. k113294 01/20/2012

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