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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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aluminum oxide powder, sumicorundum aao4s PROCERA SANDVIK, INC. k001418 07/05/2000
solar shoulder offset humeral head HOWMEDICA OSTEONICS CORP. k001419 07/27/2000
slidescan APPLIED IMAGING CORP. k001420 08/30/2000
ontrak testcup 501, model 3016633 ROCHE DIAGNOSTICS CORP. k001421 07/12/2000
psn hemodialyzer, models psn 170, psn 210 BAXTER HEALTHCARE CORP. k001422 06/02/2000
kawasumi laboratories iv administration set, primary KAWASUMI LABORATORIES AMERICA, INC. k001423 07/21/2000
kawasumi laboratories iv administration set, standard KAWASUMI LABORATORIES AMERICA, INC. k001424 07/21/2000
kawasumi laboratories iv administration set with filter KAWASUMI LABORATORIES AMERICA, INC. k001426 07/21/2000
modification to fasttake compact blood glucose monitoring system SELFCARE, INC. k001427 06/02/2000
optimum wetting and rewetting drop LOBOB LABORATORIES, INC. k001428 05/26/2000

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