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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pessary, Vaginal
510(k) Number K883721
Device Name FEMALE CONTINENCE DEVICE
Applicant
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact DEXTER J ELKINS
Correspondent
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact DEXTER J ELKINS
Regulation Number884.3575
Classification Product Code
HHW  
Date Received08/31/1988
Decision Date 10/03/1988
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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