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510(k) K890376

VAGINAL SPECULUM by Kinetic Medical Products — Product Code HFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Endometrial
Device Class
Class II
Regulation Number
884.1185
Review Panel
OB
Submission Type

Other clearances by Kinetic Medical Products

  • K890385 — MIDWIFERY/OBSTETRICAL FORCEPS (March 1, 1989)
  • K890387 — MALLEABLE PLACENTA CURETTE (February 27, 1989)
  • K890380 — CERVICAL BIOPSY FORCEPS (February 27, 1989)
  • K890382 — COMPRESSION FORCEPS (February 27, 1989)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K890383 — HYSTERECTOMY FORCEPS (February 16, 1989)
  • K890379 — UTERINE TENTACULUM (February 13, 1989)
  • K890378 — UTERINE DRESSING FORCEPS (February 13, 1989)
  • K890377 — FIXED-SIZE UTERINE DILATOR (February 13, 1989)
  • K890389 — UMBILICAL SCISSORS (February 13, 1989)

Other clearances for product code HFD

  • K891037 — WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE (March 17, 1989)
  • K810558 — SKIN SCRUB TRAY (March 17, 1981)