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FDA 510(k) Application Details - K080775
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K080775
Device Name
Tampon, Menstrual, Unscented
Applicant
TOSAMA D.D.
SARANOVICEVA CESTA 035
VIR, DOMZALE 1230 SI
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Contact
ANTONIJA VIDENSEK
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Regulation Number
884.5470
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Classification Product Code
HEB
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Date Received
03/19/2008
Decision Date
09/10/2008
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
Y
Expedited Review
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