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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 K131198
FOIA Releasable 510(k) K131198
Device Name TIPI OTC
Applicant
CONTIPI LTD.
555 THIRTEENTH ST NW
WASHINGTON,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
CONTIPI LTD.
555 THIRTEENTH ST NW
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN KAHAN
Regulation Number884.3575
Classification Product Code
HHW  
Date Received04/26/2013
Decision Date 08/27/2013
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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