FDA.reportPublic FDA data

510(k) K042267

Device
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP
Applicant
Inovel, LLC
510(k) number
K042267
Product code
MSH
Decision
Substantially Equivalent (SESE)
Decision date
2004-09-30
Date received
2004-08-23
Regulation
878.4040
Classification name
Respirator, Surgical
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
WILLIAM WAWRZYNIAK
Address
10111 W. Jefferson Blvd. Culver City CA US 90232 90232

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSH#

510(k), Device, Applicant table
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