MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS— 510(k) K062663

Name: FDA 510(k) clearance K062663
Creator: U.S. Food and Drug Administration
Published: 2006-10-11

Substantially Equivalent

Moldex/Metric, Inc.

FDA 510(k) clearance K062663 for MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, Substantially Equivalent on 2006-10-11. Applicant: Moldex/Metric, Inc.. Device class: 2.

Clearance details

Applicant: Moldex/Metric, Inc.
Product code: Code MSH
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2006-09-07
Decision date: 2006-10-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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