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FDA 510(k) Application Details - K201003
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K201003
Device Name
Tampon, Menstrual, Unscented
Applicant
Calla Lily Personal Care, Ltd.
10 Rose &Crown Yard
London SW1Y 6RE GB
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Contact
Shaun Knights
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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
04/16/2020
Decision Date
12/07/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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