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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 K940552
Device Name MONOPOLAR SURGICAL INSTRUMENTS
Applicant
Tnco, Inc.
15 Colebrook Blvd.
P.O. Box 231
Whitman,  MA  02382
Applicant Contact KARIN DOLAN
Correspondent
Tnco, Inc.
15 Colebrook Blvd.
P.O. Box 231
Whitman,  MA  02382
Correspondent Contact KARIN DOLAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/07/1994
Decision Date 05/05/1994
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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