The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Fibrelight Nasal Specula.
| Device ID | K853588 |
| 510k Number | K853588 |
| Device Name: | FIBRELIGHT NASAL SPECULA |
| Classification | Speculum, Ent |
| Applicant | DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | Jarvis Cribb |
| Correspondent | Jarvis Cribb DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | EPY |
| CFR Regulation Number | 878.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-27 |
| Decision Date | 1985-12-18 |