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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K895659
Device Name HUI MINI-FLEX
Applicant
UNIMAR, INC.
475 DANBURY RD.
WILTON,  CT  06897
Applicant Contact ANTHONY HEMMING
Correspondent
UNIMAR, INC.
475 DANBURY RD.
WILTON,  CT  06897
Correspondent Contact ANTHONY HEMMING
Regulation Number884.1700
Classification Product Code
HIG  
Date Received09/20/1989
Decision Date 12/19/1989
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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