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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)
Number
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Decision
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photon multi-platform system, model z-12834-x & z-13175-x Paradigm Medical Industries, Inc. k003318 05/22/2001
photonova family of pulsed light systems Photonova Ofsweden AB k073477 05/09/2008
pocket spirometer P.K. Morgan Instruments, Inc. k830995 04/28/1983
polycath-h catheter Abbott Laboratories k854308 04/07/1986
polychaco fia-abs test for syphilis Parasitic Disease Consultants k831296 07/26/1983
polymer coated powder-free latex examination gloves, contains 50 micrograms or less of total water extractable protein p Allegiance Healthcare Corp. k001739 07/27/2000
port-a-cath portal introducer forceps Pharmacia Deltec, Inc. k881690 05/20/1988
powder free nitrile examination gloves (tested for use with chemotherapy drugs use and simulated gastric acid) Pt. Maja Agung Latexindo k212408 05/18/2022
powder free vinyl patient examination gloves, clear (non-colored) Zhangjiangang All Fine Rubber-Plastic Products Co. k092109 10/09/2009
powdered vinyl patient glove Shijiazhuang Lianhe Shunda Plastic Products Co., L k070046 02/07/2007

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