STERILE DISPOSABLES FOR MER— 510(k) K120098

Name: FDA 510(k) clearance K120098
Creator: U.S. Food and Drug Administration
Published: 2012-06-12

Substantially Equivalent

Alpha Omega Engineering , Ltd.

FDA 510(k) clearance K120098 for STERILE DISPOSABLES FOR MER, Substantially Equivalent on 2012-06-12. Applicant: Alpha Omega Engineering , Ltd.. Device class: 2.

Clearance details

Applicant: Alpha Omega Engineering , Ltd.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2012-01-12
Decision date: 2012-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zichron Yaacov, IL

Download summary PDF View on FDA.gov ↗

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