The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Uro-flo.
| Device ID | K945140 |
| 510k Number | K945140 |
| Device Name: | URO-FLO |
| Classification | System, Irrigation, Urological |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | M L Friedman |
| Correspondent | M L Friedman MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-20 |
| Decision Date | 1995-03-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() URO-FLO 74581250 not registered Dead/Abandoned |
Liebel-Flarsheim Company 1994-10-03 |