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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 K160041
Device Name Cobbra RF Tissue Dissector
Applicant
Elliquence, LLC
2455 Grand Ave.
Baldwin,  NY  11510
Applicant Contact PAUL D. BUHRKE
Correspondent
Elliquence, LLC
2455 Grand Ave.
Baldwin,  NY  11510
Correspondent Contact PAUL D. BUHRKE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/08/2016
Decision Date 03/07/2016
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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