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510(k) K051742

OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH by Inntec, Inc. — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2005
Date Received
June 28, 2005
Clearance Type
Abbreviated
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 Inntec, Inc.

  • K052059 — IUI CATHETER, MODEL 9057 (November 22, 2005)
  • K050521 — EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023- (May 2, 2005)

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  • K171611 — Double Lumen Ovum Aspiration Needles (December 15, 2017)
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