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FDA 510(k) Application Details - K982383
Device Classification Name
Tampon, Menstrual, Scented, Deodorized
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510(K) Number
K982383
Device Name
Tampon, Menstrual, Scented, Deodorized
Applicant
PLAYTEX PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS, NJ 07652 US
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Contact
MARK ROSENGARTEN
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Regulation Number
884.5460
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Classification Product Code
HIL
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More FDA Info for this Product Code
Date Received
07/08/1998
Decision Date
08/19/1998
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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