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FDA 510(k) Application Details - K983478
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K983478
Device Name
Tampon, Menstrual, Unscented
Applicant
ORGANIC ESSENTIALS
822 BALDRIDGE ST.
O'DONNELL, TX 79351 US
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Contact
LA RHEA PEPPER
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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
10/02/1998
Decision Date
11/09/1998
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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