FDA 510(k) Application Details - K083718

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K083718
Device Name	Elastomer, Silicone, For Scar Management
Applicant	BEAU RX SOLUTIONS, LLC. PO BOX 51-1117 MELBOURNE BEACH, FL 32951 US Other 510(k) Applications for this Company
Contact	THOMAS L MCGRAW Other 510(k) Applications for this Contact
Regulation Number	878.4025   More FDA Info for this Regulation Number
Classification Product Code	MDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2008
Decision Date	01/26/2009
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