Cleared Traditional

MASK, VAPOR, MONOMER

K770690 · Howmedica Corp. · Orthopedic
Jul 1977
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K770690 is an FDA 510(k) clearance for the MASK, VAPOR, MONOMER, a Evacuator, Vapor, Cement Monomer (Class I — General Controls, product code JDY), submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1977, 99 days after receiving the submission on April 13, 1977. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4220.

Submission Details

510(k) Number K770690 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1977
Decision Date July 21, 1977
Days to Decision 99 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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