Cleared Traditional

ENDOLYMPHATIC SAC TO MASTOID T-SHUNT

K974224 · Exmoor Plastics , Ltd. · Ear, Nose, Throat

Jan 1998

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K974224 is an FDA 510(k) clearance for the ENDOLYMPHATIC SAC TO MASTOID T-SHUNT, a Tube, Shunt, Endolymphatic (Class II — Special Controls, product code ESZ), submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on January 27, 1998, 78 days after receiving the submission on November 10, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3820.

Submission Details

510(k) Number	K974224 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 1997
Decision Date	January 27, 1998
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF