Cleared Traditional

LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER

K902056 · Hollister, Inc. · Orthopedic
Oct 1990
Decision
176d
Days
Class 1
Risk

About This 510(k) Submission

K902056 is an FDA 510(k) clearance for the LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER, a Evacuator, Vapor, Cement Monomer (Class I — General Controls, product code JDY), submitted by Hollister, Inc. (Chicago, US). The FDA issued a Cleared decision on October 30, 1990, 176 days after receiving the submission on May 7, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4220.

Submission Details

510(k) Number K902056 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1990
Decision Date October 30, 1990
Days to Decision 176 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code JDY — Evacuator, Vapor, Cement Monomer
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4220

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