PRO QR ADVANCED FORMULA POWDER


Device Classification Name

dressing, wound, drug

510(k) Number K080210
Device Name PRO QR ADVANCED FORMULA POWDER
Applicant
BIOLIFE, LLC
1235 tallevast rd.
sarasota, 
FL 
34243 -3271

Applicant Contact karen o’toole
Correspondent
BIOLIFE, LLC
1235 tallevast rd.
sarasota, 
FL 
34243 -3271

Correspodent Contact karen o’toole
Classification Product Code
FRO  
Date Received 01/28/2008
Decision Date 02/10/2009
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes