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510(k) K112462

KITAZATO OPU NEEDLE by Kitazato Medical Co., Ltd. — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2012
Date Received
August 26, 2011
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

Other clearances by Kitazato Medical Co., Ltd.

  • K131491 — KITAZATO IUI CATHETER (September 11, 2013)
  • K112396 — IUI CATHETERS (November 2, 2012)

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  • K191291 — Wallace Dual Lumen Oocyte Recovery System (June 12, 2019)
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  • K171625 — Single Lumen Ovum Aspiration Needles (January 12, 2018)
  • K171611 — Double Lumen Ovum Aspiration Needles (December 15, 2017)
  • K172050 — Follicle Aspiration Set, Reduced Single Lumen (November 21, 2017)
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  • K161970 — Follicle Aspiration Set (June 14, 2017)