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FDA 510(k) Application Details - K090819
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K090819
Device Name
Tampon, Menstrual, Unscented
Applicant
ONTEX INTERNATIONAL NV
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN, TX 78746 US
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Contact
NEAL KOBER
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Regulation Number
884.5470
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Classification Product Code
HEB
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Date Received
03/25/2009
Decision Date
12/23/2009
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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