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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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espetemp (temp. cement) ESPE GMBH (US) k770923 06/01/1977
echelon circular powered stapler Ethicon Endo-Surgery, LLC k163523 04/18/2017
stratafix symmetric pds plus knotless tissue control devices, stratafix spiral pds plus knotless tissue control devices, stratafix spiral monocryl plus knotless tissue control devices, stratafix spiral monocryl knotless tissue control devices Ethicon, Inc. k182873 01/10/2019
digital electrical muscle stimulator, model ev-807 digital ems EVERYWAY MEDICAL INSTRUMENTS CO., LTD. k020750 10/31/2002
exactech alteon highly polished femoral stem Exactech, Inc. k182462 11/08/2018
starlight, model pd9012 F.P. RUBINSTEIN Y CIA S.R.L. k073317 09/03/2008
morton iui catheters FERTILITY TECHNOLOGY RESOURCES, INC. k041470 11/22/2004
riwotrack navigation system Fiagon GmbH k230700 11/20/2023
f&p evora nasal mask nasal a model (small, medium, large, wide), f&p evora nasal mask nasal fit pack/ sml (small/medium/large) a model, f&p evora nasal mask nasal sleep lab (small, medium, large, wide), f&p evora nasal mask nasal fit pack / sml (small/medium/large) sleep lab model Fisher & Paykel Healthcare Ltd. k200089 06/02/2020
flexstent biliary self-expanding stent system FLEXIBLE STENTING SOLUTIONS, INC. k121125 07/06/2012

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