The following data is part of a premarket notification filed by Urogyn Ltd. with the FDA for Dnd 101.
| Device ID | K001590 |
| 510k Number | K001590 |
| Device Name: | DND 101 |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | UROGYN LTD. 34 FAIRWAY CIRCLE Natick, MA 01760 |
| Contact | Kenneth T Burck |
| Correspondent | Kenneth T Burck UROGYN LTD. 34 FAIRWAY CIRCLE Natick, MA 01760 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-17 |
| Decision Date | 2000-08-02 |