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FDA 510(k) Application Details - K030474
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K030474
Device Name
Tampon, Menstrual, Unscented
Applicant
ROSTAM LTD.
555 13TH ST. NW
WASHINGTON, DC 20004-1109 US
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Contact
JONATHAN S KAHAN
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Regulation Number
884.5470
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Classification Product Code
HEB
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Date Received
02/12/2003
Decision Date
05/28/2004
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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