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U.S. Department of Health and Human Services

510(K) Premarket Notification
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integra (r) jarit (r) kerrison rongeurs, integra (r) ruggles (tm)-redmons (tm) kerrison rongeurs, integra (r) miltex (r) kerrison rongeurs, integra (r) meisterhand (r) kerrison rongeurs Integra Lifesciences Corp. k150428 04/16/2015
integral vii 3.25mm biointegrated dental implant system Calcitek, Inc. k946311 10/04/1995
interlink system buretrol solution sets, interlink system buretrol solution sets, continued, clearlink system buretrol s Baxter Healthcare Corp k123874 01/10/2013
interlink threaded lock cannula Bd k011858 06/19/2001
introducer for endotracheal tube Imed Corp. k820451 03/26/1982
intuitive surgical onsite for da vinci surgical systems Intuitive Surgical, Inc. k121921 10/25/2012
ipl hair removal, model: w-1095, w-1098 Shenzhen Wochuan Electronic Co., Ltd. k232124 09/14/2023
ipl sapphire ice cooling hair remove device Shenzhen Desida Technology Co., Ltd. k221635 08/31/2022
iroot bp root repair material bioaggregate paste;iroot fs fast set root repair material ;iroot bp plus root repair material Innovative Bioceramix, Inc. k222992 11/22/2022
irrisept wound debridement and cleansing system Irrimax Corporation k202222 12/14/2020

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