FDA 510(k) Application Details - K080210

Device Classification Name	More FDA Info for this Device
510(K) Number	K080210
Device Name	PRO QR ADVANCED FORMULA POWDER
Applicant	BIOLIFE, LLC 1235 TALLEVAST RD. SARASOTA, FL 34243-3271 US Other 510(k) Applications for this Company
Contact	Karen O'Toole Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2008
Decision Date	02/10/2009
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