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FDA 510(k) Application Details - K102445
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K102445
Device Name
Tampon, Menstrual, Unscented
Applicant
ROSTAM LTD.
30 NECK ROAD
OLD LYME, CT 06371 US
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Contact
ROBERT J STAAB
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Regulation Number
884.5470
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Classification Product Code
HEB
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Date Received
08/26/2010
Decision Date
11/10/2010
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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