FDA 510(k) Application Details - K132819

Device Classification Name Tampon, Menstrual, Scented, Deodorized

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510(K) Number K132819
Device Name Tampon, Menstrual, Scented, Deodorized
Applicant PLAYTEX MANUFACTURING INC.
75 COMMERCE DR.
ALLENDALE, NJ 07401 US
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Contact PUSHPA RAO
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Regulation Number 884.5460

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Classification Product Code HIL
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Date Received 09/09/2013
Decision Date 10/09/2013
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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