Cleared Traditional

K890253 - SURGICAL ELEVATOR
(FDA 510(k) Clearance)

Jan 1989
Decision
9d
Days
Class 1
Risk

K890253 is an FDA 510(k) clearance for the SURGICAL ELEVATOR. This device is classified as a Elevator, Surgical, General & Plastic Surgery (Class I - General Controls, product code GEG).

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on January 27, 1989, 9 days after receiving the submission on January 18, 1989.

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

Submission Details

510(k) Number K890253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date January 27, 1989
Days to Decision 9 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GEG — Elevator, Surgical, General & Plastic Surgery
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800

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