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 |