The following data is part of a premarket notification filed by Colab Intl., Inc. with the FDA for Colab Cocath(tm) Implanted Catheter And Depot.
| Device ID | K896197 |
| 510k Number | K896197 |
| Device Name: | COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | COLAB INTL., INC. SUITE 100 3839 ULLOA STREET New Orleans, LA 70119 |
| Contact | Morgan, M.d. |
| Correspondent | Morgan, M.d. COLAB INTL., INC. SUITE 100 3839 ULLOA STREET New Orleans, LA 70119 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-27 |
| Decision Date | 1990-07-11 |