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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 W. 70th St.
Eden Prairie,  MN  55344
Applicant Contact SCOTT D AUGUSTINE
Correspondent
Augustine Medical, Inc.
10393 W. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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