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FDA 510(k) Application Details - K143498
Device Classification Name
Media, Reproductive
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510(K) Number
K143498
Device Name
Media, Reproductive
Applicant
LifeGlobal Group, LLC
393 Soundview Road
Guilford, CT 06437 US
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Contact
MICHAEL D CECCHI
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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
12/10/2014
Decision Date
01/20/2015
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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