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510(k) K870550

TEFLON UTERINE SOUND by Cook Ob/Gyn — Product Code HHM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1987
Date Received
February 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sound, Uterine
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K983595 — TRANSMYOMETRIAL EMBRYO TRANSFER SET (February 8, 1999)
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  • K983642 — COOK MINI-INCUBATOR (February 1, 1999)
  • K983593 — OVUM PICK-UP ASPIRATION NEEDLES (January 21, 1999)

Other clearances for product code HHM

  • K011840 — CERVILENZ UTERINE MEASURING SOUND (August 10, 2001)
  • K935665 — INTRAUTERINE SOUND (February 24, 1994)
  • K884684 — ROCKET INTRAUTERINE DEPTH SOUND (December 20, 1988)
  • K883806 — ROCKET INTRAUTERINE SOUND (October 31, 1988)
  • K840380 — UTERINE SOUND (April 30, 1984)
  • K831224 — AUGROS HYSTEROMETER (October 28, 1983)
  • K802315 — UTERINE SOUND (January 12, 1981)
  • K781766 — UTERINE SOUND, BURNETT DISPOSABLE (December 7, 1978)
  • K760170 — INTRAUTERINE SOUND, PLASTIC DISPOSABLE (July 19, 1976)