Cleared Traditional

THE EXPANDACELL EAR PACK

K940133 · Denver Splint Co. · Ear, Nose, Throat
May 1994
Decision
140d
Days
Class 1
Risk

About This 510(k) Submission

K940133 is an FDA 510(k) clearance for the THE EXPANDACELL EAR PACK, a Applicator, Ent Drug (Class I — General Controls, product code LRD), submitted by Denver Splint Co. (Englewood, US). The FDA issued a Cleared decision on May 23, 1994, 140 days after receiving the submission on January 3, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5220.

Submission Details

510(k) Number K940133 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1994
Decision Date May 23, 1994
Days to Decision 140 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LRD — Applicator, Ent Drug
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5220