The following data is part of a premarket notification filed by Covalon Technologies, Inc. with the FDA for Silvercoat Silicone Foley Catheter.
| Device ID | K150550 |
| 510k Number | K150550 |
| Device Name: | SilverCoat Silicone Foley Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | COVALON TECHNOLOGIES, INC. 405 BRITANNIA RD. EAST SUITE 106 Mississauga, CA L4z 3e6 |
| Contact | Kim Crooks |
| Correspondent | Kim Crooks COVALON TECHNOLOGIES, INC. 405 BRITANNIA RD. EAST SUITE 106 Mississauga, CA L4z 3e6 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-03-03 |
| Decision Date | 2015-11-24 |
| Summary: | summary |