510(k) K042267 ยท MSH Respirator, Surgical
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP
| Applicant | Inovel, LLC, Culver City CA, US |
| Decision | Substantially Equivalent, Sep 30, 2004 |
| Received | Aug 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2009 | Inovel LLC Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010. Terminated |
MSH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.