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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K201260

Dermal Cooling System · R2 Technologies, Inc. · decided 2020-09-24 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Dermal Cooling SystemM1-SC-FR2-100-0R2 Technologies, Inc.GEH MLY00850019947533
Dermal Cooling SystemHP-005R2 Technologies, Inc.GEH MLY00850019947014
Dermal Cooling SystemHP-002R2 Technologies, Inc.GEH MLY00850019947045
Dermal Cooling SystemC2-001R2 Technologies, Inc.GEH MLY00850019947007
Dermal Cooling SystemM1-SC-FR1-100-1R2 Technologies, Inc.GEH MLY00850019947182