FDA 510(k) Application Details - K101769

Device Classification Name	Oral Wound Dressing   More FDA Info for this Device
510(K) Number	K101769
Device Name	Oral Wound Dressing
Applicant	CAMURUS AB 5 TIMBER LANE NORTH READING, MA 01864 US Other 510(k) Applications for this Company
Contact	MAUREEN O'CONNELL Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/2010
Decision Date	09/13/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review