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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wound dressing kit
510(k) Number K912232
Device Name ULCERCARE
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 Number880.5075
Classification Product Code
MCY  
Date Received05/20/1991
Decision Date 08/14/1991
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
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