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510(k) K930034

CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON by Thomasville Medical Assoc. — Product Code HDQ

K930034 is an FDA 510(k) premarket notification submitted by Thomasville Medical Assoc. for the device "CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON". The FDA issued a decision of Substantially Equivalent on February 24, 1994. The device falls under product code HDQ (Dilator, Cervical, Fixed Size), a Class I device regulated under 21 CFR 884.4530. Thomasville Medical Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1994
Date Received
January 5, 1993
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 Thomasville Medical Assoc.

  • K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (February 28, 1994)
  • K926527 — ROTO FIT BIOPSY FORCEPS (February 25, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K926532 — ENDO CERVICAL CURETTE (February 25, 1994)
  • K926535 — GOMCO CIRCUMCISION CLAMP (February 25, 1994)
  • K926540 — SOPHER AND BIERER OVUM FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K926536 — DISPOSABLE PLASTIC VAGINAL SPECULA (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926471 — MOGAN CIRCUMCISION CLAMP (February 25, 1994)

Other clearances for product code HDQ

  • 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)
  • K811568 — CERVICAL DILATOR (July 16, 1981)
  • K791277 — MODEL 6500 EXTRACTION IRRIGATION SYS (August 22, 1979)

FDA data resources