Cleared Traditional

TYMPANOPLASTY & SKIN DISSECTORS

K822569 · Kelleher Corp. · General & Plastic Surgery
Oct 1982
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K822569 is an FDA 510(k) clearance for the TYMPANOPLASTY & SKIN DISSECTORS, a Dissector, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDI), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1982, 43 days after receiving the submission on August 24, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K822569 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1982
Decision Date October 06, 1982
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GDI — Dissector, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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