INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS— 510(k) K051182

Clearance details

Applicant

Inovel, LLC

Product code

Code MSH

Device class

Class 2

Regulation

21 CFR 878.4040

Advisory panel

General, Plastic Surgery

Date received

2005-05-09

Decision date

2005-05-19

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Culver City, CA, US

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