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510(k) K890301

SHEPARD INTRAUTERINE INSEMINATION CATHETER by Cook Ob/Gyn — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1989
Date Received
January 23, 1989
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

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  • K013597 — TAMPONADE UTERINE BALLOON CATHETER SET (April 17, 2002)
  • K002385 — COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILI (September 18, 2000)
  • K002383 — COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT (September 13, 2000)
  • K983595 — TRANSMYOMETRIAL EMBRYO TRANSFER SET (February 8, 1999)
  • K983596 — INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETT (February 5, 1999)
  • K983642 — COOK MINI-INCUBATOR (February 1, 1999)
  • K983593 — OVUM PICK-UP ASPIRATION NEEDLES (January 21, 1999)

Other clearances for product code HDR

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  • 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)