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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 STREET
BURLINGTON,  MA  01803 -0738
Applicant Contact COSMAN, PHD
Correspondent
RADIONICS, INC.
P.O. BOX 438
76 CAMBRIDGE STREET
BURLINGTON,  MA  01803 -0738
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
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