INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP— 510(k) K042267

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

2004-08-23

Decision date

2004-09-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Culver City, CA, US

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