Cleared Traditional

VENESECTION TRAY, ADULT 6050

K843627 · Pro-Lab, Inc. · General & Plastic Surgery
Dec 1984
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K843627 is an FDA 510(k) clearance for the VENESECTION TRAY, ADULT 6050, a Tray, Surgical, Instrument (Class I — General Controls, product code FSM), submitted by Pro-Lab, Inc. (Round Rock, US). The FDA issued a Cleared decision on December 4, 1984, 81 days after receiving the submission on September 14, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K843627 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1984
Decision Date December 04, 1984
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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

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