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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 K885200
Device Name 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE
Applicant
Olsen Electrosurgical, Inc.
2100 Meridian Park Blvd.
Concord,  CA  94520
Applicant Contact EUGENE OLSEN
Correspondent
Olsen Electrosurgical, Inc.
2100 Meridian Park Blvd.
Concord,  CA  94520
Correspondent Contact EUGENE OLSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/16/1988
Decision Date 01/13/1989
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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