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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 K921696
Device Name CUTTING AND COAGULATION DEVICES AND ACCESSORIES
Applicant
American Cyanamid Co.
One Casper St.
Danbury,  CT  06810
Applicant Contact STEPHEN TAMSETT
Correspondent
American Cyanamid Co.
One Casper St.
Danbury,  CT  06810
Correspondent Contact STEPHEN TAMSETT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/08/1992
Decision Date 11/18/1992
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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