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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 K131361
Device Name WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
Applicant
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact STACEY A STRAND
Correspondent
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact STACEY A STRAND
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received05/13/2013
Decision Date 07/29/2013
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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