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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 K904473
Device Name KRONNER MANIPUJECTOR
Applicant
Unimar, Inc.
475 Danbury Rd.
Wilton,  CT  06897
Applicant Contact EDWARD C VOLLMER
Correspondent
Unimar, Inc.
475 Danbury Rd.
Wilton,  CT  06897
Correspondent Contact EDWARD C VOLLMER
Regulation Number884.1300
Classification Product Code
HES  
Date Received10/01/1990
Decision Date 12/14/1990
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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