Cleared Traditional

MEROGEL OTOLOGIC PACK

K001148 · Xomed, Inc. · Ear, Nose, Throat
Jun 2000
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K001148 is an FDA 510(k) clearance for the MEROGEL OTOLOGIC PACK, a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ), submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 3, 2000, 54 days after receiving the submission on April 10, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K001148 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2000
Decision Date June 03, 2000
Days to Decision 54 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KHJ — Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3620

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