Cleared Traditional

K972096 - BIVALVE NASAL SPLINT
(FDA 510(k) Clearance)

K972096 · Boston Medical Products, Inc. · Ear, Nose, Throat device

Jul 1997

Decision

41d

Days

Class 1

Risk

K972096 is an FDA 510(k) clearance for the BIVALVE NASAL 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 15, 1997, 41 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	K972096 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 04, 1997
Decision Date	July 15, 1997
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF