FDA 510(k) Application Details - K021071

Device Classification Name Syringe, Piston

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510(K) Number K021071
Device Name Syringe, Piston
Applicant BIOMET, INC.
56 EAST BELL DR.
WARSAW, IN 46581-0587 US
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Contact LONNIE WITHAM
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 04/02/2002
Decision Date 07/01/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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