The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Gastrointestinal Tube And Accessories.
| Device ID | K120182 |
| 510k Number | K120182 |
| Device Name: | NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES |
| 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 | 2012-01-20 |
| Decision Date | 2012-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20350770002563 | K120182 | 000 |
| 00350770001029 | K120182 | 000 |
| 00350770001012 | K120182 | 000 |
| 20350770001009 | K120182 | 000 |
| 00350770000992 | K120182 | 000 |
| 20350770000989 | K120182 | 000 |
| 20350770000972 | K120182 | 000 |
| 00350770000961 | K120182 | 000 |
| 00350770000954 | K120182 | 000 |
| 20350770000941 | K120182 | 000 |
| 00350770000930 | K120182 | 000 |
| 00350770000923 | K120182 | 000 |
| 20350770000910 | K120182 | 000 |
| 20350770000903 | K120182 | 000 |
| 20350770000897 | K120182 | 000 |
| 20350770001832 | K120182 | 000 |
| 20350770001870 | K120182 | 000 |
| 00350770002552 | K120182 | 000 |
| 00350770002545 | K120182 | 000 |
| 00350770002521 | K120182 | 000 |
| 00350770002514 | K120182 | 000 |
| 20350770002501 | K120182 | 000 |
| 00350770002491 | K120182 | 000 |
| 20350770002488 | K120182 | 000 |
| 00350770002477 | K120182 | 000 |
| 20350770002464 | K120182 | 000 |
| 00350770002453 | K120182 | 000 |
| 00350770002446 | K120182 | 000 |
| 20350770002433 | K120182 | 000 |
| 20350770002426 | K120182 | 000 |
| 00350770002415 | K120182 | 000 |
| 00350770000886 | K120182 | 000 |