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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 K954321
Device Name ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)
Applicant
Cytocare, Inc.
100 Columbia, Suite 100
Aliso Viejo,  CA  92656
Applicant Contact PAUL MIKUS
Correspondent
Cytocare, Inc.
100 Columbia, Suite 100
Aliso Viejo,  CA  92656
Correspondent Contact PAUL MIKUS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/13/1995
Decision Date 10/13/1995
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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