Cleared Traditional

K873044 - POREX OTOLOGY INSTRUMENTS
(FDA 510(k) Clearance)

K873044 · Porex Medical · Ear, Nose, Throat

Sep 1987

Decision

31d

Days

Class 1

Risk

K873044 is an FDA 510(k) clearance for the POREX OTOLOGY INSTRUMENTS, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on September 4, 1987, 31 days after receiving the submission on August 4, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K873044 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 1987
Decision Date	September 04, 1987
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—