The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Kolor Kode Tm.
| Device ID | K821166 |
| 510k Number | K821166 |
| Device Name: | KOLOR KODE TM |
| Classification | Instrument, Surgical, Disposable |
| Applicant | DEVON INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-26 |
| Decision Date | 1982-05-13 |