Cleared Traditional

K840311 - CAT. 7-EAR, NOSE & THROAT DEVICES
(FDA 510(k) Clearance)

K840311 · Imm Enterprises , Ltd. · Ear, Nose, Throat device
May 1984
Decision
106d
Days
Class 1
Risk

K840311 is an FDA 510(k) clearance for the CAT. 7-EAR, NOSE & THROAT DEVICES. This device is classified as a Syringe, Ent (Class I - General Controls, product code KCP).

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984, 106 days after receiving the submission on January 24, 1984.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.5220.

Submission Details

510(k) Number K840311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date May 09, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code KCP — Syringe, Ent
Device Class Class I - General Controls
CFR Regulation 21 CFR 874.5220