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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intrauterine
510(k) Number K860101
Device Name MX4040 INTRAUTERINE PRESSURE MONITORING KIT
Applicant
MEDEX, INC.
3637 LACON RD.
HILLARD,  OH  43026
Applicant Contact MESSINGER
Correspondent
MEDEX, INC.
3637 LACON RD.
HILLARD,  OH  43026
Correspondent Contact MESSINGER
Regulation Number884.2700
Classification Product Code
KXO  
Date Received01/10/1986
Decision Date 04/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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