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FDA 510(k) Application Details - K063636
Device Classification Name
System, Assisted Reproduction Laser
More FDA Info for this Device
510(K) Number
K063636
Device Name
System, Assisted Reproduction Laser
Applicant
HAMILTON THORNE BIOSCIENCES
100 CUMMINGS CENTER,
SUITE 465E
BEVERLY, MA 01915 US
Other 510(k) Applications for this Company
Contact
DOUGLAS HAMILTON
Other 510(k) Applications for this Contact
Regulation Number
884.6200
More FDA Info for this Regulation Number
Classification Product Code
MRX
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More FDA Info for this Product Code
Date Received
12/07/2006
Decision Date
04/24/2007
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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