The following data is part of a premarket notification filed by Opticon Medical, Inc. with the FDA for Option-vf Urinary Catheter, Fv14218.
| Device ID | K023090 |
| 510k Number | K023090 |
| Device Name: | OPTION-VF URINARY CATHETER, FV14218 |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | OPTICON MEDICAL, INC. 7001 POST RD., SUITE 100 Dublin, OH 43016 |
| Contact | Glenn D Brunner |
| Correspondent | Glenn D Brunner OPTICON MEDICAL, INC. 7001 POST RD., SUITE 100 Dublin, OH 43016 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-17 |
| Decision Date | 2003-03-19 |
| Summary: | summary |