Cleared Traditional

EXMOOR SUCTION CLEARANCE KIT

K990366 · Exmoor Plastics , Ltd. · Ear, Nose, Throat
Mar 1999
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K990366 is an FDA 510(k) clearance for the EXMOOR SUCTION CLEARANCE KIT, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on March 5, 1999, 28 days after receiving the submission on February 5, 1999. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K990366 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1999
Decision Date March 05, 1999
Days to Decision 28 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LRC — Instrument, Ent Manual Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420