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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K850011
Device Name PROVAC WOUND HEALING/SUCTION SET
Applicant
Medical Matrix, Inc.
P.O. Box 429378
Cincinnati,  OH  45242
Applicant Contact F CIAFARDINI
Correspondent
Medical Matrix, Inc.
P.O. Box 429378
Cincinnati,  OH  45242
Correspondent Contact F CIAFARDINI
Regulation Number878.4680
Classification Product Code
GCY  
Date Received01/02/1985
Decision Date 05/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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