Cleared Traditional

K972060 - NASAL SEPTAL BUTTON
(FDA 510(k) Clearance)

K972060 · Boston Medical Products, Inc. · Ear, Nose, Throat device

Jul 1997

Decision

31d

Days

—

Risk

K972060 is an FDA 510(k) clearance for the NASAL SEPTAL BUTTON. This device is classified as a Button, Nasal Septal.

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on July 3, 1997, 31 days after receiving the submission on June 2, 1997.

This device falls under the Ear, Nose, Throat FDA review panel.

Submission Details

510(k) Number	K972060 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 02, 1997
Decision Date	July 03, 1997
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF