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FDA 510(k) Application Details - K072600
Device Classification Name
Microtools, Assisted Reproduction (Pipettes)
More FDA Info for this Device
510(K) Number
K072600
Device Name
Microtools, Assisted Reproduction (Pipettes)
Applicant
SUNLIGHT MEDICAL, INC.
12443 SAN JOSE BLVD.
SUITE 602
JACKSONVILLE, FL 32223 US
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Contact
DUNSONG YANG
Other 510(k) Applications for this Contact
Regulation Number
884.6130
More FDA Info for this Regulation Number
Classification Product Code
MQH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2007
Decision Date
05/19/2008
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
N
Expedited Review
FDA Source Information for K072600
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