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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 COURT
MCCORDSVILLE,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
CONTIPI LTD.
6329 W. WATERVIEW COURT
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
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