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510(k) K896701

TEFLON CERVICAL ACCESS SET by Cook Ob/Gyn — Product Code HDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1990
Date Received
November 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Cervical, Fixed Size
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K023850 — SYDNEY IVF EMBRYO BIOPSY MEDIUM (January 22, 2003)
  • 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 HDQ

  • K930034 — CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON (February 24, 1994)
  • K891029 — CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL (March 17, 1989)
  • K890377 — FIXED-SIZE UTERINE DILATOR (February 13, 1989)
  • K811568 — CERVICAL DILATOR (July 16, 1981)
  • K791277 — MODEL 6500 EXTRACTION IRRIGATION SYS (August 22, 1979)