Home / 510(k) Clearances / K811568

510(k) K811568

CERVICAL DILATOR by Gynemetrics, Inc. — Product Code HDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1981
Date Received
June 4, 1981
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

Other clearances by Gynemetrics, Inc.

  • K803210 — MENSTRUAL ASPIRATION KITS (January 28, 1981)
  • K802313 — UTERINE CURETTE (January 12, 1981)
  • K802315 — UTERINE SOUND (January 12, 1981)

Other clearances for product code HDQ

  • K930034 — CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON (February 24, 1994)
  • K896701 — TEFLON CERVICAL ACCESS SET (September 13, 1990)
  • K891029 — CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL (March 17, 1989)
  • K890377 — FIXED-SIZE UTERINE DILATOR (February 13, 1989)
  • K791277 — MODEL 6500 EXTRACTION IRRIGATION SYS (August 22, 1979)