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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 K854428
Device Name VASC-EZ
Applicant
BARTON-CAREY MEDICAL PRODUCTS CO.
P.O. BOX 421
PERRYSBURG,  OH  43551
Applicant Contact JOHN H MAYS
Correspondent
BARTON-CAREY MEDICAL PRODUCTS CO.
P.O. BOX 421
PERRYSBURG,  OH  43551
Correspondent Contact JOHN H MAYS
Regulation Number880.5780
Classification Product Code
DWL  
Date Received11/05/1985
Decision Date 02/13/1986
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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