Cleared Traditional

K851763 - 13-320,13-330 TWO TYPES NAZAL SCISSORS-HEYMAN,BECK
(FDA 510(k) Clearance)

Jun 1985
Decision
47d
Days
Class 1
Risk

K851763 is an FDA 510(k) clearance for the 13-320,13-330 TWO TYPES NAZAL SCISSORS-HEYMAN,BECK. This device is classified as a Scissors, Nasal (Class I - General Controls, product code KBD).

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 11, 1985, 47 days after receiving the submission on April 25, 1985.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K851763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date June 11, 1985
Days to Decision 47 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary

Device Classification

Product Code KBD — Scissors, Nasal
Device Class Class I - General Controls
CFR Regulation 21 CFR 874.4420