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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K890637
Device Name EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
Applicant
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Applicant Contact M SOBEL,ESQ
Correspondent
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Correspondent Contact M SOBEL,ESQ
Regulation Number884.2225
Classification Product Code
HEM  
Date Received02/08/1989
Decision Date 06/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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