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FDA 510(k) Application Details - K212277
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K212277
Device Name
Tampon, Menstrual, Unscented
Applicant
Dong-A Pharmaceutical Co., Ltd.
64 Cheonho-daero, Dongdaemun-gu
Seoul 02587 KR
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Contact
Hyunjeong Jang
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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
07/20/2021
Decision Date
04/21/2022
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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