Cleared Traditional

K890256 - BONE RONGEUR, DOUBLE-ACTION (FDA 510(k) Clearance)

Jan 1989
Decision
9d
Days
Class 1
Risk

K890256 is an FDA 510(k) clearance for the BONE RONGEUR, DOUBLE-ACTION. This device is classified as a Forceps, Rongeur, Surgical (Class I - General Controls, product code EMH).

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 Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K890256 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 Dental (DE)
Summary

Device Classification

Product Code EMH — Forceps, Rongeur, Surgical
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.4565

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