Cleared Traditional

K874356 - PIN PUNCH
(FDA 510(k) Clearance)

K874356 · Med-Tool, Inc. · General & Plastic Surgery
Nov 1987
Decision
31d
Days
Class 1
Risk

K874356 is an FDA 510(k) clearance for the PIN PUNCH, 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 November 23, 1987, 31 days after receiving the submission on October 23, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K874356 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1987
Decision Date November 23, 1987
Days to Decision 31 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