FDA 510(k) Application Details - K063462

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K063462
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	NEAT STITCH LTD. HAHADAS 1 ST OR AKIVA 30600 IL Other 510(k) Applications for this Company
Contact	YOSSI MUNCHER, PH.D. 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	11/15/2006
Decision Date	01/12/2007
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