FDA.reportPublic FDA data

510(k) K232508

Device
Barrier EasyWarm Active Self-Warming Blanket
Applicant
Molnlycke Health Care Us, LLC
510(k) number
K232508
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-15
Date received
2023-08-18
Regulation
870.5900
Classification name
System, Thermal Regulating
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Megan Bevill
Address
5445 Triangle Pkwy. Suite 400 Peachtree Corners GA US 30092 30092

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DWJ#

510(k), Device, Applicant table
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