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510(k) K200446

STERIS Patient Warming System by STERIS Corporation — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2020
Date Received
February 24, 2020
Clearance Type
Abbreviated
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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