FDA 510(k) Application Details - K011372

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K011372
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	AESCULAP, INC. 13221 MARICOTTE PLACE SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	STEVE REITZLER Other 510(k) Applications for this Contact
Regulation Number	878.4493   More FDA Info for this Regulation Number
Classification Product Code	GAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2001
Decision Date	08/01/2001
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