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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 K113705
Device Name PINTLER PATIENT WARMING SYSTEM
Applicant
PINTLER MEDICAL
3220 S. HANFORD STREET
SEATTLE,  WA  98144
Applicant Contact Kent Ellis
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact PAULA WILKERSON
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received12/16/2011
Decision Date 08/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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