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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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disposbable powdered vinyl synthetic exam gloves, white color SHANGHAI PM PLASTICS ENTERISE CO., LTD. k002814 10/20/2000
lpc-plus acetabular cup PLUS ORTHOPEDICS k003274 04/06/2001
synthes synmesh spacer system SYNTHES (USA) k003275 04/23/2001
tyshak mini pediatric ptv catheter, model 107 NUMED, INC. k003276 12/01/2000
surgassist system with circular stapler disposable loading unit, model cs21,cs25,cs29,cs33 POWERMED, INC. k003277 12/21/2000
complete human tubal fluid (htf) with serum substitute supplement, model 9922 IRVINE SCIENTIFIC SALES CO., INC. k003278 01/17/2001
variant ii total ghb BIO-RAD k003280 12/19/2000
lactosorb rapidflap BIOMET, INC. k003281 08/07/2001
full auto blood pressure monitor, model se-7700h SEIN ELECTRONICS CO., LTD. k003282 11/01/2000
simplicity with wings infusion set, (model mmt-103) STERLING MEDIVATIONS, INC. k003283 12/13/2000

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