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510(k) K842943

AXCAN UTERINE SUCCION INJECTOR by Axcan Scientific Corp. — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1984
Date Received
July 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

Other clearances by Axcan Scientific Corp.

  • K831212 — ENDOSCANN (June 15, 1984)
  • K831224 — AUGROS HYSTEROMETER (October 28, 1983)
  • K831669 — AXCAN SPERM CUP (July 12, 1983)
  • K820641 — ACCURETTE (June 22, 1982)

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