Cleared Traditional

CONTAIN(TM) LASER PLUME FILTER

K902167 · Arbor Technologies, Inc. · Orthopedic
Jan 1991
Decision
234d
Days
Class 1
Risk

About This 510(k) Submission

K902167 is an FDA 510(k) clearance for the CONTAIN(TM) LASER PLUME FILTER, a Evacuator, Vapor, Cement Monomer (Class I — General Controls, product code JDY), submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on January 4, 1991, 234 days after receiving the submission on May 15, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4220.

Submission Details

510(k) Number K902167 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1990
Decision Date January 04, 1991
Days to Decision 234 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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