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510(k) K013497

FAS SET #4551 by Gynetics Medical Products NV — Product Code MQE

Clearance Details

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

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