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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 K913108
Device Name TEFLON COATED ELECTRODES/ELECTRODES HANDLES
Applicant
Olsen Electrosurgical, Inc.
2100 Meridian Park Blvd.
Concord,  CA  94520
Applicant Contact EUGENE W OLSEN
Correspondent
Olsen Electrosurgical, Inc.
2100 Meridian Park Blvd.
Concord,  CA  94520
Correspondent Contact EUGENE W OLSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/12/1991
Decision Date 12/23/1991
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
Predetermined Change
Control Plan Authorized		 No
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