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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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stryker steri-shield surgical apparel Stryker Corp. k944393 08/28/1995
stryker encore sterilizer Stryker Corp. k962755 03/04/1997
sterile polyisoprene powder free surgical gloves Better Care Plastic Technology Co., Ltd. k171047 06/22/2017
sterile instrument drape North American Sterilization & Packaging Co. k902763 09/20/1990
starkey model p1 module Starkey Laboratories, Inc. k873031 02/08/1988
spiral flow vascular arteriovenous graft Vascular Flow Technologies, Ltd. k141124 05/30/2014
spectacle frames various colors and designs Polinelli k870179 04/22/1987
spectacle frames U.S. Optical k933280 08/31/1993
spec model m-31 Source Production & Equipment Co., Inc. k090366 04/22/2009
solarcare alanine aminotransferase micro-plate assay Solarcare, Inc. k941497 05/24/1994

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