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FDA 510(k) Application Details - K202241
Device Classification Name
System, Assisted Reproduction Laser
More FDA Info for this Device
510(K) Number
K202241
Device Name
System, Assisted Reproduction Laser
Applicant
Hamilton Thorne, Inc.
100 Cummings Center, Suite 465E
Beverly, MA 01915 US
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Contact
Donald Fournier
Other 510(k) Applications for this Contact
Regulation Number
884.6200
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Classification Product Code
MRX
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More FDA Info for this Product Code
Date Received
08/10/2020
Decision Date
07/02/2021
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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