INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS— 510(k) K061859

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

2006-06-30

Decision date

2006-07-12

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Culver City, CA, US

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