FDA 510(k) Application Details - K955768

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K955768
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	BIOSCIENCE, INC. 555 THIRTEENTH ST. NW WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHN 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	12/22/1995
Decision Date	03/04/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review