Cleared Traditional

VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM

K980915 · Valleylab, Inc. · General Hospital
Jun 1998
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K980915 is an FDA 510(k) clearance for the VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on June 29, 1998, 110 days after receiving the submission on March 11, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.5070.

Submission Details

510(k) Number K980915 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1998
Decision Date June 29, 1998
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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