FDA 510(k) Application Details - K022167

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K022167
Device Name Apparatus, Autotransfusion
Applicant PALL CORP.
2200 NORTHERN BLVD.
EAST HILLS, NY 11548 US
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Contact LEONARD S BERMAN
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 07/03/2002
Decision Date 03/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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