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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 K950416
Device Name BAIR HUGGER MODEL 600 UNIT, BLANKETS
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 Received01/31/1995
Decision Date 08/29/1995
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
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