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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, suction, uterine
510(k) Number K840285
Device Name NON STRESS TEST MONITOR 507
Applicant
IMEX MEDICAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IMEX MEDICAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.5070
Classification Product Code
HGH  
Date Received01/24/1984
Decision Date 05/09/1984
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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