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510(k) K163318

Soules Intrauterine Insemination Catheter by Cook Incorporated — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2017
Date Received
November 23, 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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