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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, thermal regulating
510(k) Number K913734
Device Name BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER
Applicant
AUGUSTINE MEDICAL, INC.
10393 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Applicant Contact SCOTT D AUGUSTINE
Correspondent
AUGUSTINE MEDICAL, INC.
10393 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Correspondent Contact SCOTT D AUGUSTINE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received08/20/1991
Decision Date 10/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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