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510(k) K050521

EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S by Inntec, Inc. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2005
Date Received
March 1, 2005
Clearance Type
Abbreviated
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 Inntec, Inc.

  • K052059 — IUI CATHETER, MODEL 9057 (November 22, 2005)
  • K051742 — OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH (October 7, 2005)

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