FDA 510(k) Application Details - K970896

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K970896
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	ETHICON, INC. P.O BOX 151, ROUTE 22 WEST SOMERVILLE, NJ 08876 US Other 510(k) Applications for this Company
Contact	GREGORY JONES Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	MAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/1997
Decision Date	06/09/1997
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