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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 K010662
Device Name MODIFICATION TO 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 Received03/01/2001
Decision Date 04/27/2001
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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