Cleared Traditional

NAIL SET

K872388 · Med-Tool, Inc. · General & Plastic Surgery
Jul 1987
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K872388 is an FDA 510(k) clearance for the NAIL SET, a Punch, Surgical (Class I — General Controls, product code LRY), submitted by Med-Tool, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 23, 1987, 34 days after receiving the submission on June 19, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K872388 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1987
Decision Date July 23, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code LRY — Punch, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800