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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 K954398
Device Name INSEMI-CATH II
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Applicant Contact TAMMY BACON
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Correspondent Contact TAMMY BACON
Regulation Number884.5250
Classification Product Code
MFD  
Date Received09/20/1995
Decision Date 12/19/1995
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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