FDA 510(k) Application Details - K961925

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K961925
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
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, M.D. Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT 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	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review