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FDA 510(k) Application Details - K130609
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K130609
Device Name
Tampon, Menstrual, Unscented
Applicant
NATURALENA BRANDS, INC.
1875 S. GRANT ST.
SUITE 570
SAN MATEO, CA 94402 US
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Contact
JOSH ELLIS
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Regulation Number
884.5470
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Classification Product Code
HEB
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More FDA Info for this Product Code
Date Received
03/07/2013
Decision Date
03/21/2013
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
Y
Expedited Review
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