FDA 510(k) Application Details - K060046

Device Classification Name	Dressing,Wound,Occlusive   More FDA Info for this Device
510(K) Number	K060046
Device Name	Dressing,Wound,Occlusive
Applicant	ENZYSURGE, LTD. 291 Hillside Avenue Somerset, MA 02726 US Other 510(k) Applications for this Company
Contact	GEORGE J HATTUB 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	01/06/2006
Decision Date	02/27/2006
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