INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A— 510(k) K063747

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

2006-12-19

Decision date

2007-01-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Culver City, CA, US

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