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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 K112488
Device Name HOTDOG PATIENT WARMING SYSTEM
Applicant
AUGUSTINE BIOMEDICAL & DESIGN, LLC
6581 CITY WEST PARKWAY
EDEN PRAIRIE,  MN  55344
Applicant Contact WENDY NELSON
Correspondent
AUGUSTINE BIOMEDICAL & DESIGN, LLC
6581 CITY WEST PARKWAY
EDEN PRAIRIE,  MN  55344
Correspondent Contact WENDY NELSON
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received08/29/2011
Decision Date 11/23/2011
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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