The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Valve Cutter With Interchangeable Heads.
| Device ID | K930011 |
| 510k Number | K930011 |
| Device Name: | URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS |
| Classification | Valvulotome |
| Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | Lev Melinyshyn |
| Correspondent | Lev Melinyshyn URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-04 |
| Decision Date | 1993-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H862TIVH302 | K930011 | 000 |
| H862TIVK20302 | K930011 | 000 |
| H862TIVK2030NC2 | K930011 | 000 |
| H862TIVCNC2 | K930011 | 000 |
| H862TIVH20NC2 | K930011 | 000 |
| H862TIVH30NC2 | K930011 | 000 |
| H862TIVH40NC2 | K930011 | 000 |
| H862TIVC2 | K930011 | 000 |
| H862TIVH202 | K930011 | 000 |
| H862TIVH402 | K930011 | 000 |