Cleared Traditional

RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT

K882244 · Richards Medical Co., Inc. · Ear, Nose, Throat
Jun 1988
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K882244 is an FDA 510(k) clearance for the RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT, a Splint, Nasal (Class I — General Controls, product code EPP), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on June 23, 1988, 23 days after receiving the submission on May 31, 1988. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5800.

Submission Details

510(k) Number K882244 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1988
Decision Date June 23, 1988
Days to Decision 23 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code EPP — Splint, Nasal
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5800

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