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510(k) K892546

TAYLOR SPINAL RETRACTOR by Zinnanti Surgical Instruments, Inc. — Product Code HAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1989
Date Received
April 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type

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  • 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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