UROFLEX
Stent, Ureteral
ANGIOMED U.S., INC.
The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Uroflex.
Pre-market Notification Details
| Device ID | K854908 |
| 510k Number | K854908 |
| Device Name: | UROFLEX |
| Classification | Stent, Ureteral |
| Applicant | ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Contact | Richard P Mohr |
| Correspondent | Richard P Mohr ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-09 |
| Decision Date | 1986-03-14 |
Trademark Results [UROFLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UROFLEX 87380994 not registered Dead/Abandoned |
Tepha, Inc. 2017-03-22 |
 UROFLEX 78030338 2612758 Dead/Cancelled |
Eutech Medical AB 2000-10-12 |
 UROFLEX 77157613 not registered Dead/Abandoned |
Epoxytec Intl, Inc. 2007-04-16 |
 UROFLEX 75677993 2443304 Dead/Cancelled |
Prairie Technology Group, Inc. 1999-04-02 |
 UROFLEX 73560997 not registered Dead/Abandoned |
ANGIOMED GMBH INSTRUMENTE FUR DIE MEDIZINISCHE DIAGNOSTIK 1985-10-01 |
 UROFLEX 72402151 0945033 Dead/Expired |
NORTH AMERICAN URETHANES, INC. 1971-09-07 |
 UROFLEX 72060156 0680236 Dead/Expired |
LERMER PLASTICS, INC. 1958-10-06 |
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