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510(k) K891029

CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL by Zinnanti Surgical Instruments, Inc. — Product Code HDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1989
Date Received
February 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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  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K926021 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE (April 7, 1994)
  • K925958 — SCISSOR FOR LAPAROSCOPIC SURGERY GU USE (March 24, 1994)
  • K926181 — ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY (December 17, 1993)
  • K926016 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE (November 12, 1993)

Other clearances for product code HDQ

  • K930034 — CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON (February 24, 1994)
  • K896701 — TEFLON CERVICAL ACCESS SET (September 13, 1990)
  • K890377 — FIXED-SIZE UTERINE DILATOR (February 13, 1989)
  • K811568 — CERVICAL DILATOR (July 16, 1981)
  • K791277 — MODEL 6500 EXTRACTION IRRIGATION SYS (August 22, 1979)