The following data is part of a premarket notification filed by Neoseed Technology,llc with the FDA for Dfiner Urological Catheter.
| Device ID | K013360 |
| 510k Number | K013360 |
| Device Name: | DFINER UROLOGICAL CATHETER |
| Classification | Catheter, Urethrographic, Male |
| Applicant | NEOSEED TECHNOLOGY,LLC 22 HILL ST. Newburyport, MA |
| Contact | Mark Kieras |
| Correspondent | Mark Kieras NEOSEED TECHNOLOGY,LLC 22 HILL ST. Newburyport, MA |
| Product Code | FGI |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-10 |
| Decision Date | 2002-02-20 |
| Summary: | summary |