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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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kodak surecell hcg-serum/urine test kit, modification Eastman Kodak Company k936138 04/08/1994
klein surgical infiltration pump, model kip-ii Hk Surgical, Inc. k031432 08/07/2003
kenz-ecg 102 Compumed, Inc. k863965 12/22/1986
karl storz irrigation and suction system handpiece and accessories Karl Storz Endoscopy-America, Inc. k935785 05/11/1994
k-y brand warming jelly personal lubricant Personal Products Company, Div. of Mcneil-Ppc, Inc. k040164 04/05/2004
k-shield zen (model numbers: pbmh/ pbma/ pbm) Sb-Kawasumi Laboratories, Inc. k230408 06/01/2023
jai Intl. Trade Management Co. k951513 05/25/1995
ivobase cad for zenotec, ivobase cad bond, ivobase cad modelling liquid Wieland Dental + Technik GmbH & Co. KG k151142 08/13/2015
irrisept wound debridement and cleansing system Irrimax Corporation k202222 12/14/2020
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

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