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510(k) K013536

EMTRAC; DELPHIN; SEMTRAC 2000 SET by Gynetics Medical Products NV — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2001
Date Received
October 23, 2001
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 Gynetics Medical Products NV

  • K041237 — ECHOSAMPLER (September 8, 2004)
  • K013501 — IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B (November 30, 2001)
  • K013497 — FAS SET #4551 (November 9, 2001)

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  • K180302 — Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, S (October 24, 2018)