Cleared Traditional

CURETTE SET, ANTRUM, COAKLEY

K872609 · Military Engineering, Inc. · Ear, Nose, Throat
Jul 1987
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K872609 is an FDA 510(k) clearance for the CURETTE SET, ANTRUM, COAKLEY, a Curette, Nasal (Class I — General Controls, product code KAP), submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 15, 1987, 9 days after receiving the submission on July 6, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K872609 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1987
Decision Date July 15, 1987
Days to Decision 9 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary

Device Classification

Product Code KAP — Curette, Nasal
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420