FDA 510(k) Application Details - K202403

Device Classification Name Condom

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510(K) Number K202403
Device Name Condom
Applicant TTK Healthcare Limited
12, K P Natham Road, Thiruvandar Koil,
Puducherry 605102 IN
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Contact Daniel J. S.
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Regulation Number 884.5300

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Classification Product Code HIS
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Date Received 08/21/2020
Decision Date 04/15/2021
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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