Cleared Traditional

K890252 - BONE CURETTE (FDA 510(k) Clearance)

Jan 1989
Decision
9d
Days
Class 1
Risk

K890252 is an FDA 510(k) clearance for the BONE CURETTE. This device is classified as a Curette (Class I - General Controls, product code HTF).

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 K890252 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 HTF — Curette
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800