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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Cervical
510(k) Number K950714
Device Name COOK INSEMINATION CUP
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact DARCY JOB
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact DARCY JOB
Regulation Number884.5250
Classification Product Code
HDR  
Date Received02/15/1995
Decision Date 05/11/1995
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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