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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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510(K)
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Decision
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pituitary board Bionix Development Corp. k933614 10/07/1993
pk2025/pk2045 programmable video controller Perkins Mfg. Co. k893644 08/09/1989
pleur-evac(r) a-7002--adult/pediatric drainage Deknatel, Inc. k884844 01/24/1989
plexur m Osteotech, Inc. k073405 03/03/2008
polaris bipolar electrosurgical generator (29-1000); polaris irrigation module (29-1600); polaris light source module (29-1900); dual footswitch (29-1020) Kirwan Surgical Products, LLC k231872 08/25/2023
porocoat mark ii total elbow Depuy, Inc. k872084 06/25/1987
port-a-trac Port-A-Trac Co. k861554 06/19/1986
powder free latex examination gloves, blue, tested for use with chemotherapy drugs Gx Corporation Sdn Bhd k091643 11/02/2009
powder-free latex examination gloves Pacificlink Exp.Industries Private , Ltd. k942856 12/07/1994
powder-free vinyl examination gloves Shen Wei (Usa), Inc. k033693 01/16/2004

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