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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 K092807
Device Name HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
Applicant
Augustine Biomedical & Design, LLC
6581 City W. Pkwy.
Eden Prairie,  MN  55344
Applicant Contact JAMES ECKLEIN
Correspondent
Augustine Biomedical & Design, LLC
6581 City W. Pkwy.
Eden Prairie,  MN  55344
Correspondent Contact JAMES ECKLEIN
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received09/11/2009
Decision Date 12/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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