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FDA 510(k) Application Details - K980478
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K980478
Device Name
Tampon, Menstrual, Unscented
Applicant
PLAYTEX, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS, NJ 07653 US
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Contact
MARK ROSENGARTEN
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Regulation Number
884.5470
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Classification Product Code
HEB
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Date Received
02/06/1998
Decision Date
04/03/1998
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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