The following data is part of a premarket notification filed by Vomed Volzer Medizintechnik Gmbh & Co. with the FDA for Vomed Urethra Olive, Models 1420 000, 1425 000, 1430 000.
| Device ID | K023019 |
| 510k Number | K023019 |
| Device Name: | VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 |
| Classification | Catheter, Urethrographic, Male |
| Applicant | VOMED VOLZER MEDIZINTECHNIK GMBH & CO. 152B BRIDGE ST. Hot Springs, NC 28743 |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser VOMED VOLZER MEDIZINTECHNIK GMBH & CO. 152B BRIDGE ST. Hot Springs, NC 28743 |
| Product Code | FGI |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-11 |
| Decision Date | 2002-12-10 |