The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Quick Switch Valve With Enfit Connector.
| Device ID | K191759 |
| 510k Number | K191759 |
| Device Name: | Medline Quick Switch Valve With ENFit Connector |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Dinah Rincones |
| Correspondent | Dinah Rincones Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2019-12-04 |