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FDA 510(k) Application Details - K092578
Device Classification Name
Media, Reproductive
More FDA Info for this Device
510(K) Number
K092578
Device Name
Media, Reproductive
Applicant
GENX INTL., INC.
393 SOUNDVIEW RD.
GUILFORD, CT 06437 US
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Contact
MICHAEL D CECCHI
Other 510(k) Applications for this Contact
Regulation Number
884.6180
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Classification Product Code
MQL
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More FDA Info for this Product Code
Date Received
08/21/2009
Decision Date
04/05/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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