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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 K881687
Device Name CAVITRON ELECTROSURGICAL MODULE (CEM) AND PAK
Applicant
Cavitron Surgical Systems
88 Hamilton Ave.
P.O. Box 10133
Stamford,  CT  06904
Applicant Contact JANIS BROCK
Correspondent
Cavitron Surgical Systems
88 Hamilton Ave.
P.O. Box 10133
Stamford,  CT  06904
Correspondent Contact JANIS BROCK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/19/1988
Decision Date 06/20/1988
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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