FDA 510(k) Application Details - K963293

Device Classification Name	Dressing,Wound And Burn,Occlusive,Heated   More FDA Info for this Device
510(K) Number	K963293
Device Name	Dressing,Wound And Burn,Occlusive,Heated
Applicant	AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	SCOTT D AUGUSTINE Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MSA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/1996
Decision Date	03/28/1997
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review