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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 K060526
Device Name TIPI
Applicant
Contipi , Ltd.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
Contipi , Ltd.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL DRYDEN
Regulation Number884.3575
Classification Product Code
HHW  
Date Received02/27/2006
Decision Date 06/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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