FDA 510(k) Application Details - K964620

Device Classification Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K964620
Device Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant	SAGE PHARMACEUTICALS, INC. 5408 INTERSTATE DR. SHREVEPORT, LA 71109 US Other 510(k) Applications for this Company
Contact	WILLIAM J ROCHE Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MGQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1996
Decision Date	01/09/1997
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