The following data is part of a premarket notification filed by Inovel Llc with the FDA for Inovel Health Care N95 Particulate Respirators & Surgical Masks.
| Device ID | K061859 |
| 510k Number | K061859 |
| Device Name: | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS |
| Classification | Respirator, Surgical |
| Applicant | INOVEL LLC 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3509 |
| Contact | William Wawrzyniak |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-30 |
| Decision Date | 2006-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 5092311151705 | K061859 | 000 |
| 00092311151304 | K061859 | 000 |
| 50092311151200 | K061859 | 000 |
| 50092311151101 | K061859 | 000 |