The following data is part of a premarket notification filed by Uromed Corp. with the FDA for Uro Med Nerve Stimulator.
| Device ID | K970971 |
| 510k Number | K970971 |
| Device Name: | URO MED NERVE STIMULATOR |
| Classification | Stimulator, Nerve |
| Applicant | UROMED CORP. 64 A ST. Needham, MA 02194 |
| Contact | Frederick Tobia |
| Correspondent | Frederick Tobia UROMED CORP. 64 A ST. Needham, MA 02194 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-17 |
| Decision Date | 1997-10-27 |
| Summary: | summary |