The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Enteral Only Extension Set.
| Device ID | K100288 |
| 510k Number | K100288 |
| Device Name: | NEOMED ENTERAL ONLY EXTENSION SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-01 |
| Decision Date | 2010-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00350770002019 | K100288 | 000 |
| 00350770000329 | K100288 | 000 |
| 20350770000293 | K100288 | 000 |
| 00350770000282 | K100288 | 000 |
| 00350770000275 | K100288 | 000 |
| 00350770000268 | K100288 | 000 |
| 20350770000231 | K100288 | 000 |
| 20350770000224 | K100288 | 000 |
| 20350770000217 | K100288 | 000 |
| 00350770000176 | K100288 | 000 |
| 00350770000169 | K100288 | 000 |
| 00350770000336 | K100288 | 000 |
| 00350770000343 | K100288 | 000 |
| 20350770000354 | K100288 | 000 |
| 00350770002002 | K100288 | 000 |
| 20350770001993 | K100288 | 000 |
| 00350770001982 | K100288 | 000 |
| 20350770001979 | K100288 | 000 |
| 00350770001968 | K100288 | 000 |
| 00350770001951 | K100288 | 000 |
| 20350770001948 | K100288 | 000 |
| 00350770001937 | K100288 | 000 |
| 20350770001924 | K100288 | 000 |
| 00350770001913 | K100288 | 000 |
| 00350770000152 | K100288 | 000 |