MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG


Device Classification Name

dressing, wound, drug

510(k) Number K110062
Device Name MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG
Applicant
MEDIPURPOSE PTE. LTD.
111 laurel ridge drive
alpharetta, 
GA 
30004

Applicant Contact julie stephens
Correspondent
MEDIPURPOSE PTE. LTD.
111 laurel ridge drive
alpharetta, 
GA 
30004

Correspodent Contact julie stephens
Classification Product Code
FRO  
Date Received 01/10/2011
Decision Date 09/01/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes