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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K914367
Device Name ELECTROSURGICAL GENERATOR MODEL ESU100/250/550
Applicant
Gyne-Tech Instrument Corp.
1111 Chestnut St.
Burbank,  CA  91506
Applicant Contact J.KERMIT FLOYD
Correspondent
Gyne-Tech Instrument Corp.
1111 Chestnut St.
Burbank,  CA  91506
Correspondent Contact J.KERMIT FLOYD
Regulation Number884.4120
Classification Product Code
HGI  
Date Received10/01/1991
Decision Date 04/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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