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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 trauma plating system HOWMEDICA OSTEONICS CORP. k000636 05/11/2000
suni max SATELEC k000049 04/04/2000
supercross catheter ABBOTT VASCULAR INC. k001856 03/07/2001
supergloves sterile powdered latex examination gloves SUPERMAX GLOVE MANUFACTURING SDN BHD k000644 03/17/2000
suresample-wallace endometrial sampler, endo 26 SIMS PORTEX LTD. k001555 08/02/2000
surgi-vision esophageal stylet coil SURGI-VISION, INC. k994436 03/14/2000
surgiflator-40 W.O.M. GMHB k001533 07/31/2000
surgitron iec ii ELLMAN INTL., INC. k001253 05/26/2000
surshield winged infusion set TERUMO MEDICAL CORP. k010103 03/15/2001
synchron systems alcohol reagent and calibrators BECKMAN COULTER, INC. k000410 04/10/2000

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