The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Microtek Intranasal Splint.
| Device ID | K862496 |
| 510k Number | K862496 |
| Device Name: | MICROTEK INTRANASAL SPLINT |
| Classification | Splint, Nasal |
| Applicant | MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| Contact | Frank Lockhart |
| Correspondent | Frank Lockhart MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| Product Code | EPP |
| CFR Regulation Number | 874.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-01 |
| Decision Date | 1986-07-14 |