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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleeve, limb, compressible
510(k) Number K963672
Device Name MODEL 90022 ROLLING STAND
Applicant
AUGUSTINE MEDICAL, INC.
10393 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Applicant Contact SCOTT D AUGUSTINE, M.D.
Correspondent
AUGUSTINE MEDICAL, INC.
10393 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Correspondent Contact SCOTT D AUGUSTINE, M.D.
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/13/1996
Decision Date 01/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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