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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sound, Uterine
510(k) Number K840380
Device Name UTERINE SOUND
Applicant
INTL. MEDICAL TECHNOLOGIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INTL. MEDICAL TECHNOLOGIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.4530
Classification Product Code
HHM  
Date Received01/30/1984
Decision Date 04/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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