Cleared Traditional

PLUMEMASTER SMOKE EVACUATION SYSTEM

K930434 · Sorenson Laboratories, Inc. · General Hospital
Nov 1993
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K930434 is an FDA 510(k) clearance for the PLUMEMASTER SMOKE EVACUATION SYSTEM, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Sorenson Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 16, 1993, 294 days after receiving the submission on January 26, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.5070.

Submission Details

510(k) Number K930434 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1993
Decision Date November 16, 1993
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FYD — Apparatus, Exhaust, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5070

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