FDA 510(k) Application Details - K961931

Device Classification Name	Suture, Absorbable, Natural   More FDA Info for this Device
510(K) Number	K961931
Device Name	Suture, Absorbable, Natural
Applicant	R.K. MEDICAL, L.L.C. ONE LETHBRIDGE PLAZA SUITE 4 MAHWAH, NJ 07430 US Other 510(k) Applications for this Company
Contact	BRENDA M KELLY Other 510(k) Applications for this Contact
Regulation Number	878.4830   More FDA Info for this Regulation Number
Classification Product Code	GAL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/1996
Decision Date	07/29/1996
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