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FDA 510(k) Application Details - K051446
Device Classification Name
Tampon, Menstrual, Scented, Deodorized
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510(K) Number
K051446
Device Name
Tampon, Menstrual, Scented, Deodorized
Applicant
FIRST QUALITY HYGIENIC INC.
73 FRANKLIN TPK
ALLENDALE, NJ 07401 US
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Contact
ROBERT J STAAB
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Regulation Number
884.5460
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Classification Product Code
HIL
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Date Received
06/02/2005
Decision Date
07/14/2005
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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