Cleared Traditional

K871072 - OMEGA NASAL SEPTAL BUTTON
(FDA 510(k) Clearance)

K871072 · Omega Silicone, Inc. · Ear, Nose, Throat device

Jun 1987

Decision

82d

Days

—

Risk

K871072 is an FDA 510(k) clearance for the OMEGA NASAL SEPTAL BUTTON. This device is classified as a Button, Nasal Septal.

Submitted by Omega Silicone, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on June 8, 1987, 82 days after receiving the submission on March 18, 1987.

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

Submission Details

510(k) Number	K871072 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 18, 1987
Decision Date	June 08, 1987
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—