The following data is part of a premarket notification filed by Conco Medical Co. with the FDA for Finger Protector.
| Device ID | K820381 | 
| 510k Number | K820381 | 
| Device Name: | FINGER PROTECTOR | 
| Classification | Splint, Hand, And Components | 
| Applicant | CONCO MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | ILH | 
| CFR Regulation Number | 890.3475 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1982-02-09 | 
| Decision Date | 1982-03-01 |