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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
510(k) Number K883633
Device Name ULTRACARE
Applicant
Jobst Institute, Inc.
Box 653
Toledo,  OH  43694
Applicant Contact WETZEL, C.M.
Correspondent
Jobst Institute, Inc.
Box 653
Toledo,  OH  43694
Correspondent Contact WETZEL, C.M.
Regulation Number880.5780
Classification Product Code
DWL  
Date Received08/25/1988
Decision Date 10/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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