FDA 510(k) Application Details - K961389

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K961389
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
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	878.5010   More FDA Info for this Regulation Number
Classification Product Code	GAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/1996
Decision Date	06/18/1996
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