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FDA 510(k) Application Details - K980703
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
More FDA Info for this Device
510(K) Number
K980703
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
AESCULAP, INC.
ONE AMERICA PLAZA, SUITE 900
600 WEST BROADWAY
SAN DIEGO, CA 92101-3302 US
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Contact
STEVE REITZLER
Other 510(k) Applications for this Contact
Regulation Number
878.5010
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Classification Product Code
GAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/23/1998
Decision Date
05/04/1998
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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