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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Blood, Non-Electromagnetic Radiation
510(k) Number K973741
Device Name BAIR HUGGER BLOOD/FLUID WARMER
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 Number864.9205
Classification Product Code
BSB  
Date Received10/01/1997
Decision Date 04/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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