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510(k) K041237

ECHOSAMPLER by Gynetics Medical Products NV — Product Code HFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2004
Date Received
May 11, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspirator, Endometrial
Device Class
Class II
Regulation Number
884.1060
Review Panel
OB
Submission Type

Other clearances by Gynetics Medical Products NV

  • 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)
  • K013497 — FAS SET #4551 (November 9, 2001)

Other clearances for product code HFF

  • K903002 — PROBET (TM) (April 5, 1991)
  • K902693 — WALLACH FLEXIBLE ENDOMETRIAL SAMPLER (January 31, 1991)
  • K831212 — ENDOSCANN (June 15, 1984)
  • K820641 — ACCURETTE (June 22, 1982)