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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 K860826
Device Name VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE
Applicant
BAUERFEIND GMBH & CO.
811-D LIVINGSTON COURT
MARIETTA,  GA  30067
Applicant Contact GEORGE M MOHR
Correspondent
BAUERFEIND GMBH & CO.
811-D LIVINGSTON COURT
MARIETTA,  GA  30067
Correspondent Contact GEORGE M MOHR
Regulation Number880.5780
Classification Product Code
DWL  
Date Received03/04/1986
Decision Date 06/18/1986
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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