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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 K001149
FOIA Releasable 510(k) K001149
Device Name AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
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 Received04/10/2000
Decision Date 09/06/2000
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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