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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, carbon-dioxide, uterotubal (and accessories)
510(k) Number K841682
Device Name UTERINE INJECTOR 4.0MM
Applicant
HUMI CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HUMI CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.1300
Classification Product Code
HES  
Date Received04/23/1984
Decision Date 07/03/1984
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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