The following data is part of a premarket notification filed by Opticon Medical, Inc. with the FDA for Option-vf Urinary Catheter With Adaptor, Model Fva14218; Option-v Continuous Drainage Adaptor, Model Cda1000.
| Device ID | K033830 |
| 510k Number | K033830 |
| Device Name: | OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | OPTICON MEDICAL, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Gerard J Prud'homme, Esq. |
| Correspondent | Gerard J Prud'homme, Esq. OPTICON MEDICAL, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-10 |
| Decision Date | 2004-01-09 |
| Summary: | summary |