The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Umi Percutaneous Transhepatic Cholan.
| Device ID | K833937 |
| 510k Number | K833937 |
| Device Name: | UMI PERCUTANEOUS TRANSHEPATIC CHOLAN |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-15 |
| Decision Date | 1984-01-03 |