FDA 510(k) Application Details - K964953

Device Classification Name	Staple Driver   More FDA Info for this Device
510(K) Number	K964953
Device Name	Staple Driver
Applicant	INFLUENCE, INC. 12307 WINESAP TERRACE NORTH POTOMAC, MD 20878-2331 US Other 510(k) Applications for this Company
Contact	MARK D KRAMER Other 510(k) Applications for this Contact
Regulation Number	888.4540   More FDA Info for this Regulation Number
Classification Product Code	HXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/1996
Decision Date	02/13/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review