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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
Model PPWS-1
Device Name PINTLER PATIENT WARMING SYSTEM
Original Applicant
PINTLER MEDICAL
3220 s. hanford street
seattle,  WA  98144
Original Contact maribeth macintyre-ellis
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received12/16/2011
Decision Date 08/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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