FDA 510(k) Application Details - K001703

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K001703
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant ABBOTT VASCULAR INC.
400 SAGINAW DR.
REDWOOD CITY, CA 94063 US
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Contact DENISE C SUNGLETON
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 06/05/2000
Decision Date 10/03/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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