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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 WEST PARKWAY
EDEN PRAIRIE,  MN  55344
Applicant Contact JAMES ECKLEIN
Correspondent
AUGUSTINE BIOMEDICAL & DESIGN, LLC
6581 CITY WEST PARKWAY
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
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