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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K201131
Device Name firefly T-2
Applicant
Firstkind Limited
Hawk House, Peregrine Business Park
High Wycombe,  GB HP13 7DL
Applicant Contact Neil Buckley
Correspondent
Heyer Regulatory Solutions LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number890.5850
Classification Product Code
NGX  
Date Received04/28/2020
Decision Date 05/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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