The following data is part of a premarket notification filed by Uromed Corp. with the FDA for Uromed Sling Kit.
| Device ID | K980717 |
| 510k Number | K980717 |
| Device Name: | UROMED SLING KIT |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | UROMED CORP. 64 A ST. Needham, MA 02194 |
| Contact | Nancy Macdonald |
| Correspondent | Nancy Macdonald UROMED CORP. 64 A ST. Needham, MA 02194 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-24 |
| Decision Date | 1998-05-22 |
| Summary: | summary |