FDA 510(k) Application Details - K050495

Device Classification Name Syringe, Piston

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510(K) Number K050495
Device Name Syringe, Piston
Applicant BAXTER HEALTHCARE CORP., BIOSCIENCE
ONE BAXTER WAY
WESTLAKE VILLAGE, CA 91362 US
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Contact RON LAGERQUIST
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 02/28/2005
Decision Date 05/02/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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