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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 K870149
Device Name MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.
Applicant
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Applicant Contact COSMAN, PHD
Correspondent
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Correspondent Contact COSMAN, PHD
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/13/1987
Decision Date 04/06/1987
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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