The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Oral/enteral Syringes With Enfit Connector (12 Ml To 60 Ml), Low Dose Tip Oral/enteral Syringes With Enfit Connector (1 Ml To 6 Ml).
| Device ID | K183540 |
| 510k Number | K183540 |
| Device Name: | Oral/Enteral Syringes With ENFit Connector (12 ML To 60 ML), Low Dose Tip Oral/Enteral Syringes With ENFit Connector (1 ML To 6 ML) |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | NeoMed, Inc. 100 Londonderry Ct, Suite 112 Woodstock, GA 30188 |
| Contact | Tony Lair |
| Correspondent | Melinda Smith NeoMed, Inc. 100 Londonderry Court, Suite 112 Woodstock, GA 30188 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-20 |
| Decision Date | 2019-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10350770001491 | K183540 | 000 |
| 10350770001477 | K183540 | 000 |
| 10350770001453 | K183540 | 000 |
| 10350770001439 | K183540 | 000 |