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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 K000480
Device Name ACTIVE ELECTRODE MONITORING SYSTEM
Applicant
ELECTROSCOPE, INC.
PO BOX 219
INDIAN HILLS,  CO  80454
Applicant Contact LYNNE ARONSON
Correspondent
ELECTROSCOPE, INC.
PO BOX 219
INDIAN HILLS,  CO  80454
Correspondent Contact LYNNE ARONSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/14/2000
Decision Date 05/02/2000
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
Recalls CDRH Recalls
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