Cleared Traditional

EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)

K972700 · Exmoor Plastics , Ltd. · Ear, Nose, Throat
Jul 1998
Decision
393d
Days
Class 2
Risk

About This 510(k) Submission

K972700 is an FDA 510(k) clearance for the EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN), a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ), submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on July 16, 1998, 393 days after receiving the submission on June 18, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K972700 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1997
Decision Date July 16, 1998
Days to Decision 393 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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