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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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kallestad quantitope low level ige reag KALLESTAD LABORATORIES, INC. k811545 06/24/1981
k-laser ELTECH S.R.L k120604 05/25/2012
jumong series SG HEALTHCARE CO LTD k150816 05/08/2015
juggerknotless soft anchors, juggerknotless m soft anchors, juggerknotless soft anchors with needles, juggerknotless sof BIOMET SPORTS MEDICINE k123485 03/18/2013
jr implant system LK Consulting Group USA, Inc. k130694 06/19/2014
jelonet paraffin gauze dressings ACME UNITED CORP. k791573 09/04/1979
iv armboards FIBRE FORMATIONS, INC. k781233 08/14/1978
itotal identity cruciate retaining (cr) knee replacement system, itotal identity posterior stabilizing (ps) knee replacement system Conformis Inc. k210252 02/17/2021
isite pacs, v 4. x STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO. k063267 11/09/2006
ipl hair removal, model: w-1095, w-1098 Shenzhen Wochuan Electronic Co., Ltd k232124 09/14/2023

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