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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K922681
Device Name CUTINOVA FOAM
Applicant
Jobst Institute, Inc.
Box 653
Toledo,  OH  43694
Applicant Contact ANGELO R PEREIRA
Correspondent
Jobst Institute, Inc.
Box 653
Toledo,  OH  43694
Correspondent Contact ANGELO R PEREIRA
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/04/1992
Decision Date 08/31/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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