FDA 510(k) Application Details - K964935

Device Classification Name	Retention Device, Suture   More FDA Info for this Device
510(K) Number	K964935
Device Name	Retention Device, Suture
Applicant	SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	SUSAN A FINNERAN Other 510(k) Applications for this Contact
Regulation Number	878.4930   More FDA Info for this Regulation Number
Classification Product Code	KGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/1996
Decision Date	02/25/1997
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