Cleared Traditional

AEROSOL DELIVERY SYSTEMS

K920842 · Hospitak, Inc. · Ear, Nose, Throat
May 1992
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K920842 is an FDA 510(k) clearance for the AEROSOL DELIVERY SYSTEMS, a Applicator, Ent Drug (Class I — General Controls, product code LRD), submitted by Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on May 15, 1992, 81 days after receiving the submission on February 24, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5220.

Submission Details

510(k) Number K920842 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1992
Decision Date May 15, 1992
Days to Decision 81 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