FDA 510(k) Application Details - K051842

Device Classification Name Condom

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510(K) Number K051842
Device Name Condom
Applicant CUPID CONDOM, LTD.
A-68, MIDC SINNAR, (MALEGAON)
NASHIK, MAHARASHTRA 422 113 IN
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Contact K.K. GOYAL
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Regulation Number 884.5300

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Classification Product Code HIS
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Date Received 07/07/2005
Decision Date 04/14/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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