The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Enfit Connectors.
| Device ID | K151628 |
| 510k Number | K151628 |
| Device Name: | Medline ENFit Connectors |
| Classification | Enteral Specific Transition Connectors |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Stephanie Blair |
| Correspondent | Stephanie Blair MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | PIO |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-17 |
| Decision Date | 2015-07-24 |
| Summary: | summary |