FDA 510(k) Application Details - K952344

Device Classification Name Tampon, Menstrual, Scented, Deodorized

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510(K) Number K952344
Device Name Tampon, Menstrual, Scented, Deodorized
Applicant TAMBRANDS, INC.
777 WESTCHESTER AVE.
WHITE PLAINS, NY US
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Contact JEROME B EAINICK
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Regulation Number 884.5460

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Classification Product Code HIL
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Date Received 05/19/1995
Decision Date 07/28/1995
Decision SE - Substantially Equivalent
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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