FDA 510(k) Application Details - K963396

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K963396
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	INSTRUMENT MAKAR, INC. C/O ABOOD,ABOOD & RHEAUME,P.C. 117 EAST ALLEGAN STREET LANSING, MI 48933 US Other 510(k) Applications for this Company
Contact	ANDREW P ABOOD 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	08/28/1996
Decision Date	05/06/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review