FDA 510(k) Application Details - K980704

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K980704
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	AESCULAP, INC. ONE AMERICA PLAZA, SUITE 900 600 WEST BROADWAY SAN DIEGO, CA 92101-3302 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	02/23/1998
Decision Date	05/11/1998
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