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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Intrauterine Insemination
510(k) Number K910317
Device Name UNI-SEM(TM)
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 Number884.5250
Classification Product Code
MFD  
Date Received01/24/1991
Decision Date 05/01/1991
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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