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FDA 510(k) Application Details - K180850
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K180850
Device Name
Tampon, Menstrual, Unscented
Applicant
Thinx, Inc.
601 W 26th Street, Suite 515
New York, NY 10001 US
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Contact
Kerrie Timmons
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Regulation Number
884.5470
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Classification Product Code
HEB
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Date Received
04/02/2018
Decision Date
08/20/2018
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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