Cleared Traditional

BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO

K790877 · Stackhouse Assoc. · Orthopedic
May 1979
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K790877 is an FDA 510(k) clearance for the BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO, a Evacuator, Vapor, Cement Monomer (Class I — General Controls, product code JDY), submitted by Stackhouse Assoc. (Walker, US). The FDA issued a Cleared decision on May 23, 1979, 16 days after receiving the submission on May 7, 1979. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4220.

Submission Details

510(k) Number K790877 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1979
Decision Date May 23, 1979
Days to Decision 16 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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