The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Enfit Syringe.
| Device ID | K160642 |
| 510k Number | K160642 |
| Device Name: | Medline ENFit Syringe |
| Classification | Gastrointestinal Tubes With Enteral Specific 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 | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888277677712 | K160642 | 000 |