Cleared Traditional

K972317 - MONTGOMERY THYROPLASTY IMPLANT SYSTEM
(FDA 510(k) Clearance)

K972317 · Boston Medical Products, Inc. · Ear, Nose, Throat device

Sep 1997

Decision

90d

Days

Class 2

Risk

K972317 is an FDA 510(k) clearance for the MONTGOMERY THYROPLASTY IMPLANT SYSTEM. This device is classified as a System, Vocal Cord Medialization (Class II - Special Controls, product code MIX).

Submitted by Boston Medical Products, Inc. (North Attleboro, US). The FDA issued a Cleared decision on September 18, 1997, 90 days after receiving the submission on June 20, 1997.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K972317 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 20, 1997
Decision Date	September 18, 1997
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF