Cleared Traditional

CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000

K862509 · Lifestream Int'L, Inc. · Orthopedic
Jul 1986
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K862509 is an FDA 510(k) clearance for the CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000, a Evacuator, Vapor, Cement Monomer (Class I — General Controls, product code JDY), submitted by Lifestream Int'L, Inc. (Sugar Land, US). The FDA issued a Cleared decision on July 23, 1986, 22 days after receiving the submission on July 1, 1986. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4220.

Submission Details

510(k) Number K862509 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1986
Decision Date July 23, 1986
Days to Decision 22 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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