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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 K002680
Device Name TISSUELINK MONOPOLAR FLOATING BALL'
Applicant
TISSUELINK MEDICAL, INC.
ONE WASHINGTON CENTER
SUITE 400
DOVER,  NH 
Applicant Contact ROBERTA THOMPSON
Correspondent
TISSUELINK MEDICAL, INC.
ONE WASHINGTON CENTER
SUITE 400
DOVER,  NH 
Correspondent Contact ROBERTA THOMPSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/28/2000
Decision Date 11/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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