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510(k) K831669

AXCAN SPERM CUP by Axcan Scientific Corp. — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
May 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type

Other clearances by Axcan Scientific Corp.

  • K842943 — AXCAN UTERINE SUCCION INJECTOR (September 21, 1984)
  • K831212 — ENDOSCANN (June 15, 1984)
  • K831224 — AUGROS HYSTEROMETER (October 28, 1983)
  • K820641 — ACCURETTE (June 22, 1982)

Other clearances for product code HDR

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  • K222969 — FERTI-LILY Conception Cup (June 23, 2023)
  • K993953 — OVES CERVICAL CAP (March 21, 2000)
  • K945131 — IMAGYN INTRAUTERINE INSEMINATION DEVICE (May 15, 1995)
  • K950714 — COOK INSEMINATION CUP (May 11, 1995)
  • K902171 — MINISPACE(TM) IUI CATHETER (October 5, 1990)
  • K902694 — COAXIAL CATHETER SET (August 28, 1990)
  • K896960 — INTRAUTERINE INSEMINATION CATHETERS (June 26, 1990)
  • K900316 — MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (April 16, 1990)
  • K900308 — SPERM SELECT SYSTEM (April 13, 1990)