The following data is part of a premarket notification filed by Lazarus Medical Innovations, Inc. with the FDA for Lmi Cholangiogram Tray.
| Device ID | K873471 |
| 510k Number | K873471 |
| Device Name: | LMI CHOLANGIOGRAM TRAY |
| Classification | Catheter, Cholangiography |
| Applicant | LAZARUS MEDICAL INNOVATIONS, INC. UNIV. OF UTAH RESEARCH PARK 40 SOUTH REDWOOD RD. #102 North Salt Lake, UT 84054 |
| Contact | Dixon Ford |
| Correspondent | Dixon Ford LAZARUS MEDICAL INNOVATIONS, INC. UNIV. OF UTAH RESEARCH PARK 40 SOUTH REDWOOD RD. #102 North Salt Lake, UT 84054 |
| Product Code | GBZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-28 |
| Decision Date | 1987-10-23 |