Cleared Traditional

EAR APPLICATOR, CATALOG NO. 2229

K870762 · Treace Medical, Inc. · General Hospital
Mar 1987
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K870762 is an FDA 510(k) clearance for the EAR APPLICATOR, CATALOG NO. 2229, a Applicator, Absorbent Tipped, Non-sterile (Class I — General Controls, product code KXF), submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on March 6, 1987, 8 days after receiving the submission on February 26, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6025.

Submission Details

510(k) Number K870762 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1987
Decision Date March 06, 1987
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KXF — Applicator, Absorbent Tipped, Non-sterile
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6025