The following data is part of a premarket notification filed by Uromed Corp. with the FDA for Uromed Alternative Bladder Control Continence Device(abcpn-0026).
| Device ID | K971992 |
| 510k Number | K971992 |
| Device Name: | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) |
| Classification | Clamp, Penile |
| 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 | FHA |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1997-08-01 |
| Summary: | summary |