Cleared Traditional

K891889 - OLIVECORONA SCISSORS
(FDA 510(k) Clearance)

Apr 1989
Decision
19d
Days
Class 1
Risk

K891889 is an FDA 510(k) clearance for the OLIVECORONA SCISSORS. This device is classified as a Scissors, General, Surgical (Class I - General Controls, product code LRW).

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 12, 1989, 19 days after receiving the submission on March 24, 1989.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K891889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date April 12, 1989
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code LRW — Scissors, General, Surgical
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800

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