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 |