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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Dr.
Alpharetta,  GA  30004
Applicant Contact JULIE STEPHENS
Correspondent
Medipurpose Pte. , Ltd.
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact JULIE STEPHENS
Classification Product Code
FRO  
Date Received01/10/2011
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
Predetermined Change
Control Plan Authorized		 No
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