FDA 510(k) Application Details - K990088

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K990088
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant AESCULAP, INC.
ONE AMERICA PLAZA, SUITE 900
600 WEST BROADWAY
SAN DIEGO, CA 92101-3302 US
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Contact STEVE REITZLER
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 01/11/1999
Decision Date 02/10/1999
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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