Cleared Traditional

'EXMOOR' ATKINS NASAL SPLINT

K864930 · Exmoor Plastics , Ltd. · Ear, Nose, Throat
Mar 1987
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K864930 is an FDA 510(k) clearance for the 'EXMOOR' ATKINS NASAL SPLINT, a Splint, Nasal (Class I — General Controls, product code EPP), submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on March 4, 1987, 78 days after receiving the submission on December 16, 1986. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5800.

Submission Details

510(k) Number K864930 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1986
Decision Date March 04, 1987
Days to Decision 78 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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