The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Catheter, Silicone Coated.
| Device ID | K772218 |
| 510k Number | K772218 |
| Device Name: | CATHETER, SILICONE COATED |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-02 |
| Decision Date | 1977-12-13 |