510(k) K051182 ยท MSH Respirator, Surgical
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
| Applicant | Inovel, LLC, Culver City CA, US |
| Decision | Substantially Equivalent, May 19, 2005 |
| Received | May 9, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K051182
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2006 | Inovel LLC Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161. Terminated |
MSH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.