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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Obstetric
510(k) Number K861371
Device Name TRANSVAGINAL PROBE, MODEL ED65M-TV
Applicant
Elscint, Inc.
751 Expy. Dr.
Itasca,  IL  60143
Applicant Contact ROBERT E KENNEY
Correspondent
Elscint, Inc.
751 Expy. Dr.
Itasca,  IL  60143
Correspondent Contact ROBERT E KENNEY
Regulation Number884.2960
Classification Product Code
HGL  
Date Received04/11/1986
Decision Date 07/14/1986
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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