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510(k) K892255

DENTAL ROOT ELEVATOR by Zinnanti Surgical Instruments, Inc. — Product Code EKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1989
Date Received
April 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Denture Preformed (Partially Prefabricated Denture)
Device Class
Class II
Regulation Number
872.3600
Review Panel
DE
Submission Type

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  • K941457 — UTERINE INJECTOR WITH SPRING (January 24, 1995)
  • K925560 — ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES (August 30, 1994)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925957 — SCISSORS 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 EKO

  • K903672 — DENE BRIDGE (December 5, 1990)
  • K780722 — ADVANCED DENTURE SYSTEM (May 26, 1978)
  • K760768 — FLEXIDENT DENTURE (October 15, 1976)