FDA 510(k) Application Details - K961870

Device Classification Name Tampon, Menstrual, Scented, Deodorized

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510(K) Number K961870
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 IRWIN BUTENSKY, PH.D.
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Regulation Number 884.5460

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Classification Product Code HIL
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Date Received 05/10/1996
Decision Date 06/19/1996
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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