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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 K922999
Device Name SEGAL REUSABLE ELECTRODE
Applicant
Bernsco Surgical Supply, Inc.
6653 NE Windermere Rd.
Seattle,  WA  98115
Applicant Contact GERALD BERNSTEIN
Correspondent
Bernsco Surgical Supply, Inc.
6653 NE Windermere Rd.
Seattle,  WA  98115
Correspondent Contact GERALD BERNSTEIN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/22/1992
Decision Date 11/27/1992
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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