The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Glo-tip Spray Catheter.
| Device ID | K182319 |
| 510k Number | K182319 |
| Device Name: | Glo-Tip Spray Catheter |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Paula Joyce |
| Correspondent | Daniel J. Dillon MED Institute 1330 Win Hentschel Boulevard West Lafayette, IN 47906 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-27 |
| Decision Date | 2019-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002248922 | K182319 | 000 |