The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Coloshield Kit.
| Device ID | K855121 |
| 510k Number | K855121 |
| Device Name: | COLOSHIELD KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| 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 | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-01-08 |