The following data is part of a premarket notification filed by Uromed Corp. with the FDA for Uromed Patch.
| Device ID | K974600 |
| 510k Number | K974600 |
| Device Name: | UROMED PATCH |
| Classification | External Urethral Occluder, Urinary Incontinence-control, Female |
| 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 | MNG |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-09 |
| Decision Date | 1998-03-31 |
| Summary: | summary |