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System, Thermal Regulating

FDA product code DWJ · 157 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.5900
Review panel
CV
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1976-12-06 – 2026-08-21

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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