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510(k) K162667

Kitazato IUI Catheter by Kitazato Corporation — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2017
Date Received
September 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6110
Review Panel
OB
Submission Type

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