The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Wilson-cook Colonic Z-stent.
| Device ID | K990034 |
| 510k Number | K990034 |
| Device Name: | WILSON-COOK COLONIC Z-STENT |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | MED INSTITUTE, INC. 1400 CUMBERLAND AVE. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot MED INSTITUTE, INC. 1400 CUMBERLAND AVE. P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-06 |
| Decision Date | 2000-04-17 |
| Summary: | summary |