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510(k) K013501

IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B by Gynetics Medical Products NV — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2001
Date Received
October 22, 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)
  • K013536 — EMTRAC; DELPHIN; SEMTRAC 2000 SET (November 30, 2001)
  • K013497 — FAS SET #4551 (November 9, 2001)

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