The following data is part of a premarket notification filed by Secol Co. with the FDA for Metal Splints.
| Device ID | K810109 |
| 510k Number | K810109 |
| Device Name: | METAL SPLINTS |
| Classification | Splint, Hand, And Components |
| Applicant | SECOL CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ILH |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-16 |
| Decision Date | 1981-01-26 |