PRONTOSAN WOUND IRRIGATION SOLUTION


Device Classification Name

dressing, wound, drug

510(k) Number K072876
Device Name PRONTOSAN WOUND IRRIGATION SOLUTION
Applicant
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Applicant Contact rebecca stolarick
Correspondent
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Correspodent Contact rebecca stolarick
Classification Product Code
FRO  
Date Received 10/09/2007
Decision Date 06/19/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes