Cleared Traditional

MASTER KIT B

K861142 · Pro-Lab, Inc. · General & Plastic Surgery
Jul 1986
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K861142 is an FDA 510(k) clearance for the MASTER KIT B, a Tray, Surgical (Class I — General Controls, product code LRP), submitted by Pro-Lab, Inc. (Birmingham, US). The FDA issued a Cleared decision on July 10, 1986, 106 days after receiving the submission on March 26, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K861142 FDA.gov
FDA Decision Cleared SESD
Date Received March 26, 1986
Decision Date July 10, 1986
Days to Decision 106 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code LRP — Tray, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800