510(k) K210603

3M Bair Hugger Temperature Management System (Model 675) by 3M Company — Product Code DWJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 30, 2021
Date Received: March 1, 2021
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Thermal Regulating
Device Class: Class II
Regulation Number: 870.5900
Review Panel: CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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