Cleared Traditional

EAR CANNULAS

K822201 · Kelleher Corp. · General & Plastic Surgery
Oct 1982
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K822201 is an FDA 510(k) clearance for the EAR CANNULAS, a Cannula, Injection (Class I — General Controls, product code FGY), submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on October 6, 1982, 75 days after receiving the submission on July 23, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K822201 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1982
Decision Date October 06, 1982
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FGY — Cannula, Injection
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4200