EMULSION SB


Device Classification Name

dressing, wound, drug

510(k) Number K110732
Device Name EMULSION SB
Applicant
PRUGEN IP HOLDINGS, INC
8711 e pinnacle peak road
suite c-201, pmb 225
scottsdale, 
AZ 
85255

Applicant Contact robert l knechtel
Correspondent
PRUGEN IP HOLDINGS, INC
8711 e pinnacle peak road
suite c-201, pmb 225
scottsdale, 
AZ 
85255

Correspodent Contact robert l knechtel
Classification Product Code
FRO  
Date Received 03/16/2011
Decision Date 06/03/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No