The following data is part of a premarket notification filed by Inovel Llc with the FDA for Inovel Health Care N95 Particulate Respirators And Surgical Masks, Models Mfrn95-s, Mfrn95-xs, Mfrn95-ml, Mfrn95-a.
| Device ID | K063747 |
| 510k Number | K063747 |
| Device Name: | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A |
| Classification | Respirator, Surgical |
| Applicant | INOVEL LLC 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3509 |
| Contact | William Warzyniak |
| Correspondent | Daniel W Lehtonen 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-12-19 |
| Decision Date | 2007-01-12 |
| Summary: | summary |