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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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Decision
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multiple private labels, nitrile exam gloves, powder-free (white) SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. k001549 06/12/2000
multi-pulse 2000 IMAGING SCIENCES INTL., INC. k001248 05/04/2000
multi-function defibrillation electrode MEDICOTEST A/S k002079 02/22/2001
multi purpose flex array coil : model 235 series MEDICAL ADVANCES, INC. k000345 04/11/2000
multi adjustable face mask ORTHO TECHNOLOGY k000358 06/09/2000
motorized micro multileaf collimator STRYKER LEIBINGER k000349 05/03/2000
monofilament biosyn suture UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k000037 03/30/2000
modular rotating hinge knee crossover tibial bearing components HOWMEDICA OSTEONICS CORP. k001548 06/07/2000
modular porp and torp model tbd GYRUS ENT L.L.C. k002378 08/29/2000
modofication to vitro immunodiagnostic products psa reagent pack, vitro immunodiagnostic products psa calibrators Ortho-Clinical Diagnostics, Inc. k000566 03/09/2000

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