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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 K790418
Device Name MODEL 8100 PRE-FILLED INTRAUTERINE
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2700
Classification Product Code
KXO  
Date Received02/28/1979
Decision Date 03/21/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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