Cleared Traditional

AROMAPATCH

K984345 · Envis, Inc. · Ear, Nose, Throat
Mar 1999
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K984345 is an FDA 510(k) clearance for the AROMAPATCH, a Applicator, Ent Drug (Class I — General Controls, product code LRD), submitted by Envis, Inc. (Asheville, US). The FDA issued a Cleared decision on March 19, 1999, 105 days after receiving the submission on December 4, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5220.

Submission Details

510(k) Number K984345 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1998
Decision Date March 19, 1999
Days to Decision 105 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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