The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Medela Low Dose Enteral Syringe.
| Device ID | K161811 |
| 510k Number | K161811 |
| Device Name: | Medela Low Dose Enteral Syringe |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | Medela, Inc. 785 Challenger Street Brea, CA 92821 |
| Contact | Fergie Ferguson |
| Correspondent | Fergie Ferguson Medela, Inc. 785 Challenger Street Brea, CA 92821 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-01 |
| Decision Date | 2017-02-15 |
| Summary: | summary |