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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 K094056
Device Name HOTDOG MULTI FUNCTION CONTROLLER
Applicant
AUGUSTINE BIOMEDICAL & DESIGN, LLC
6581 CITY WEST PARKWAY
EDEN PRAIRIE,  MN  55344
Applicant Contact JAMES ECKLEIN
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received12/31/2009
Decision Date 06/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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