The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Enfit Otc Feeding Syringe.
| Device ID | K202285 |
| 510k Number | K202285 |
| Device Name: | Medline ENfit OTC Feeding Syringe |
| Classification | Enteral Syringes 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 | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-12 |
| Decision Date | 2020-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40193489036658 | K202285 | 000 |