FDA 510(k) Application Details - K091133

Device Classification Name	Dressing,Wound,Occlusive   More FDA Info for this Device
510(K) Number	K091133
Device Name	Dressing,Wound,Occlusive
Applicant	APLION MEDICAL,LLC 2425 SOUTH 900 WEST SALT LAKE CITY, UT 84119 US Other 510(k) Applications for this Company
Contact	CURTIS JENSEN Other 510(k) Applications for this Contact
Regulation Number	878.4020   More FDA Info for this Regulation Number
Classification Product Code	NAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2009
Decision Date	05/20/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review