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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K943494
Device Name HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY
Applicant
LYCO ENTERPRISES, INC.
4727 OSBORNE DR.,
BLDG. A, SUITE 100
EL PASO,  TX  79922 -1011
Applicant Contact JOHN J O'CONNOR
Correspondent
LYCO ENTERPRISES, INC.
4727 OSBORNE DR.,
BLDG. A, SUITE 100
EL PASO,  TX  79922 -1011
Correspondent Contact JOHN J O'CONNOR
Regulation Number884.4530
Classification Product Code
LKF  
Date Received07/19/1994
Decision Date 07/06/1995
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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