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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K162490
Device Name Disc-FX System
Applicant
Elliquence, LLC
2455 Grand Ave.
Baldwin,  NY  11510
Applicant Contact Paul D. Buhrke IV
Correspondent
Elliquence, LLC
2455 Grand Ave.
Baldwin,  NY  11510
Correspondent Contact Paul D. Buhrke IV
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HRX  
Date Received09/07/2016
Decision Date 01/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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