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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 K910227
Device Name MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER
Applicant
MEDEX, INC.
3637 LACON RD.
HILLARD,  OH  43026
Applicant Contact CATHY CHENETSKI
Correspondent
MEDEX, INC.
3637 LACON RD.
HILLARD,  OH  43026
Correspondent Contact CATHY CHENETSKI
Regulation Number884.2700
Classification Product Code
KXO  
Date Received01/18/1991
Decision Date 04/03/1991
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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