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510(k) K882054

HYSTERO KIT by Zinnanti Surgical Instruments, Inc. — Product Code HDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1988
Date Received
May 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K925560 — ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES (August 30, 1994)
  • 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)

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