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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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positube PARAPRODUCTS, INC. k000045 03/15/2000
polymer coated, powder free, latex examination gloves with protein content labeling claim (50 micrograms or less) FLEXITECH SDN. BHD. k994354 01/31/2000
polymer coated powder free nitrile examination gloves, blue FLEXITECH SDN. BHD. k994416 02/03/2000
polyglycolic acid (pga), absorbable surgical suture (usp) CP MEDICAL k002190 08/10/2000
pm 2002 proline/aec PLANMECA OY k000163 04/18/2000
plr splined revision stem BIOMET, INC. k994184 02/15/2000
plastic port implantable venous access system SIMS DELTEC, INC. k994216 01/27/2000
philips ct secura mv PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. k000819 05/12/2000
phalangeal fixation system MEDCANICA, INC. k994232 03/01/2000
perry-kolberg (pk) ha-coated titanium sleeve INTEGRATED ORBITAL IMPLANTS, INC. k000151 04/10/2000

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