The following data is part of a premarket notification filed by Urologics, Inc. with the FDA for Urostat.
| Device ID | K854539 |
| 510k Number | K854539 |
| Device Name: | UROSTAT |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | UROLOGICS, INC. 1538 CATRON AVE., S.E. Albuquerque, NM 87123 |
| Contact | Edwin H Barsis |
| Correspondent | Edwin H Barsis UROLOGICS, INC. 1538 CATRON AVE., S.E. Albuquerque, NM 87123 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-13 |
| Decision Date | 1986-02-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UROSTAT 73567920 1399300 Dead/Cancelled |
UROLOGICS, INC. 1985-11-12 |
![]() UROSTAT 73272471 1219660 Dead/Cancelled |
Uro-Research, Inc. 1980-07-31 |