Cleared Traditional

K972092 - NASAL AIRWAY SPLINT
(FDA 510(k) Clearance)

K972092 · Boston Medical Products, Inc. · Ear, Nose, Throat device

Jul 1997

Decision

34d

Days

Class 1

Risk

K972092 is an FDA 510(k) clearance for the NASAL AIRWAY SPLINT. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on July 8, 1997, 34 days after receiving the submission on June 4, 1997.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number	K972092 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 04, 1997
Decision Date	July 08, 1997
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF