FDA 510(k) Application Details - K131198

Device Classification Name Pessary, Vaginal

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510(K) Number K131198
Device Name Pessary, Vaginal
Applicant CONTIPI LTD.
555 THIRTEENTH ST NW
WASHINGTON, DC 20004 US
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Contact JONATHAN KAHAN
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Regulation Number 884.3575

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Classification Product Code HHW
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Date Received 04/26/2013
Decision Date 08/27/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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