FDA 510(k) Application Details - K021062

Device Classification Name

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510(K) Number K021062
Device Name CHITO-SEAL
Applicant ABBOTT VASCULAR INC.
400 SAGINAW DR.
REDWOOD CITY, CA 94063 US
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Contact SEVRINA CIUCCI
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Regulation Number

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Classification Product Code QSY
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Date Received 04/02/2002
Decision Date 08/23/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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