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FDA 510(k) Application Details - K070745
Device Classification Name
Tampon, Menstrual, Scented, Deodorized
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510(K) Number
K070745
Device Name
Tampon, Menstrual, Scented, Deodorized
Applicant
PLAYTEX PRODUCTS, INC.
804 WALKER RD.
DOVER, DE 19904 US
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Contact
KEITH EDGETT
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Regulation Number
884.5460
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Classification Product Code
HIL
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Date Received
03/19/2007
Decision Date
04/13/2007
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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