FDA 510(k) Application Details - K964581

Device Classification Name	Suture, Nonabsorbable, Silk   More FDA Info for this Device
510(K) Number	K964581
Device Name	Suture, Nonabsorbable, Silk
Applicant	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. NORWALK, CT 06856 US Other 510(k) Applications for this Company
Contact	JANET G JOHNSON Other 510(k) Applications for this Contact
Regulation Number	878.5030   More FDA Info for this Regulation Number
Classification Product Code	GAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/1996
Decision Date	01/16/1997
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