Cleared Traditional

MASTER KIT A

K850246 · Pro-Lab, Inc. · General & Plastic Surgery
Apr 1985
Decision
77d
Days
Risk

About This 510(k) Submission

K850246 is an FDA 510(k) clearance for the MASTER KIT A, submitted by Pro-Lab, Inc. (Birmingham, US). The FDA issued a Cleared decision on April 9, 1985, 77 days after receiving the submission on January 22, 1985. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K850246 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1985
Decision Date April 09, 1985
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class