FDA 510(k) Application Details - K971095

Device Classification Name	Gauze/Sponge, Internal   More FDA Info for this Device
510(K) Number	K971095
Device Name	Gauze/Sponge, Internal
Applicant	OPPORTUNITY, INC. 1200 OLD SKOKIE RD. HIGHLAND PARK, IL 60035 US Other 510(k) Applications for this Company
Contact	JAMES S SANDERS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	EFQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/1997
Decision Date	09/16/1997
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review