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510(k) K112396

IUI CATHETERS by Kitazato Medical Co., Ltd. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2012
Date Received
August 19, 2011
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

Other clearances by Kitazato Medical Co., Ltd.

  • K131491 — KITAZATO IUI CATHETER (September 11, 2013)
  • K112462 — KITAZATO OPU NEEDLE (November 26, 2012)

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