FDA 510(k) Application Details - K974891

Device Classification Name	Dressing, Wound And Burn, Occlusive   More FDA Info for this Device
510(K) Number	K974891
Device Name	Dressing, Wound And Burn, Occlusive
Applicant	ACUTEK ADHESIVE SPECIALTIES, INC. 540 NORTH OAK ST. INGLEWOOD, CA 90302 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MGP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/1997
Decision Date	10/21/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review