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510(k) K131491

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2013
Date Received
May 23, 2013
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.

  • K112462 — KITAZATO OPU NEEDLE (November 26, 2012)
  • K112396 — IUI CATHETERS (November 2, 2012)

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