The following data is part of a premarket notification filed by Opticon Medical with the FDA for Option-vm Urinary Catheter/adpater, Models Mv39016, Mva39016.
| Device ID | K041983 |
| 510k Number | K041983 |
| Device Name: | OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | OPTICON MEDICAL 7001 POST RD., SUITE 100 Dublin, OH 43016 |
| Contact | Glenn D Brunner |
| Correspondent | Glenn D Brunner OPTICON MEDICAL 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 | 2004-07-23 |
| Decision Date | 2004-11-17 |
| Summary: | summary |