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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 K914329
Device Name SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION
Applicant
Ellman Intl. Mfg., Inc.
C/O # Amer Tech Serv Corp.
407 E. Main St., P.O. Box 347
Port Jefferson,  NY  11777
Applicant Contact RICHARD LANZILLOTTO
Correspondent
Ellman Intl. Mfg., Inc.
C/O # Amer Tech Serv Corp.
407 E. Main St., P.O. Box 347
Port Jefferson,  NY  11777
Correspondent Contact RICHARD LANZILLOTTO
Regulation Number884.4120
Classification Product Code
HGI  
Date Received09/27/1991
Decision Date 04/02/1992
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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