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510(k) K162881

Kitazato OPU Needles by Kitazato Corporation — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2017
Date Received
October 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6100
Review Panel
OB
Submission Type

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