The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Dekna Band Kit.
| Device ID | K862115 |
| 510k Number | K862115 |
| Device Name: | DEKNA BAND KIT |
| Classification | Bandage, Cast |
| Applicant | DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Contact | Orofino |
| Correspondent | Orofino DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Product Code | ITG |
| CFR Regulation Number | 890.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-03 |
| Decision Date | 1986-08-19 |