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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K011375
Device Name AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
Applicant
AESCULAP, INC.
13221 MARICOTTE PLACE
SAN DIEGO,  CA  92130
Applicant Contact STEVE REITZLER
Correspondent
AESCULAP, INC.
13221 MARICOTTE PLACE
SAN DIEGO,  CA  92130
Correspondent Contact STEVE REITZLER
Regulation Number878.4493
Classification Product Code
GAM  
Date Received05/04/2001
Decision Date 06/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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