WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET

System, Thermal Regulating

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Warmtouch Surgical Access Blanket, Warmtouch Torso Blanket.

Pre-market Notification Details

Device IDK131361
510k NumberK131361
Device Name:WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
ClassificationSystem, Thermal Regulating
Applicant COVIDIEN 6135 GUNBARREL AVE. Boulder,  CO  80301
ContactStacey A Strand
CorrespondentStacey A Strand
COVIDIEN 6135 GUNBARREL AVE. Boulder,  CO  80301
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-13
Decision Date2013-07-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521141114 K131361 000
20884521141121 K131361 000

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