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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K112458
Device Name PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Applicant
Medica-Rents Co., Ltd.
P.O. Box 205
Derby,  CT  06418
Applicant Contact DINA L WEISSMAN, J.D.
Correspondent
Medica-Rents Co., Ltd.
P.O. Box 205
Derby,  CT  06418
Correspondent Contact DINA L WEISSMAN, J.D.
Regulation Number878.4780
Classification Product Code
OMP  
Date Received08/26/2011
Decision Date 01/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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