PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S— 510(k) K041855

Name: FDA 510(k) clearance K041855
Creator: U.S. Food and Drug Administration
Published: 2004-11-10

Substantially Equivalent

Aearo Co.

FDA 510(k) clearance K041855 for PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S, Substantially Equivalent on 2004-11-10. Applicant: Aearo Co.. Device class: 2.

Clearance details

Applicant: Aearo Co.
Product code: Code MSH
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2004-07-09
Decision date: 2004-11-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Southbridge, MA, US

Download summary PDF View on FDA.gov ↗

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