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510(k) K831212

ENDOSCANN by Axcan Scientific Corp. — Product Code HFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1984
Date Received
April 14, 1983
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 Axcan Scientific Corp.

  • K842943 — AXCAN UTERINE SUCCION INJECTOR (September 21, 1984)
  • K831224 — AUGROS HYSTEROMETER (October 28, 1983)
  • K831669 — AXCAN SPERM CUP (July 12, 1983)
  • K820641 — ACCURETTE (June 22, 1982)

Other clearances for product code HFF

  • K041237 — ECHOSAMPLER (September 8, 2004)
  • K903002 — PROBET (TM) (April 5, 1991)
  • K902693 — WALLACH FLEXIBLE ENDOMETRIAL SAMPLER (January 31, 1991)
  • K820641 — ACCURETTE (June 22, 1982)