The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Oral/enteral Syringe.
| Device ID | K122373 |
| 510k Number | K122373 |
| Device Name: | NEOMED ORAL/ENTERAL SYRINGE |
| Classification | Syringe, Piston |
| Applicant | NEOMED, INC. 100 Londonderry Ct Suite 112 Woodstock, GA 30188 |
| Contact | Melinda Harrison |
| Correspondent | Melinda Harrison NEOMED, INC. 100 Londonderry Ct Suite 112 Woodstock, GA 30188 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2012-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10350770002788 | K122373 | 000 |
| 10350770002658 | K122373 | 000 |
| 10350770002641 | K122373 | 000 |
| 10350770002634 | K122373 | 000 |
| 10350770002627 | K122373 | 000 |
| 10350770002610 | K122373 | 000 |
| 10350770002603 | K122373 | 000 |
| 10350770002597 | K122373 | 000 |
| 10350770002580 | K122373 | 000 |
| 10350770002665 | K122373 | 000 |
| 10350770002672 | K122373 | 000 |
| 10350770002689 | K122373 | 000 |
| 10350770002771 | K122373 | 000 |
| 10350770002764 | K122373 | 000 |
| 10350770002740 | K122373 | 000 |
| 10350770002733 | K122373 | 000 |
| 10350770002726 | K122373 | 000 |
| 10350770002719 | K122373 | 000 |
| 10350770002702 | K122373 | 000 |
| 10350770002696 | K122373 | 000 |
| 10350770002573 | K122373 | 000 |