FDA 510(k) Application Details - K020223

Device Classification Name Condom

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510(K) Number K020223
Device Name Condom
Applicant INDUS MEDICARE LTD.
144, S.P. RD., BEGUMPET
HYDERABAD ANDHRA PRADESH 500 016 IN
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Contact P. K REDDY
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Regulation Number 884.5300

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Classification Product Code HIS
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Date Received 01/22/2002
Decision Date 03/04/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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