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FDA 510(k) Application Details - K182813
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K182813
Device Name
Tampon, Menstrual, Unscented
Applicant
Cotton High Tech, SL
Colonia La Rabeia, S/N
Balsareny 08660 ES
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Contact
Anna Garcia Llado
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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
10/03/2018
Decision Date
03/15/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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