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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 K912780
Device Name MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD
Applicant
ELECTROSCOPE, INC.
4890 STERLING DR.
BOULDER,  CO  80301
Applicant Contact ROGER C.ODELL
Correspondent
ELECTROSCOPE, INC.
4890 STERLING DR.
BOULDER,  CO  80301
Correspondent Contact ROGER C.ODELL
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/24/1991
Decision Date 12/30/1991
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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