The following data is part of a premarket notification filed by Conco Medical Co. with the FDA for Finger Cot.
Device ID | K820383 |
510k Number | K820383 |
Device Name: | FINGER COT |
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 | 1982-02-24 |