FDA 510(k) Application Details - K965162

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K965162
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	LUKENS MEDICAL CORP. THE LAHR CONSULTING GROUP,INC. ONE LETHBRIDGE PLAZA MAHWAH, NJ 07430 US Other 510(k) Applications for this Company
Contact	BRENDA M KELLY 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	12/24/1996
Decision Date	02/12/1997
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