The following data is part of a premarket notification filed by Entracare, Llc with the FDA for Entracare Gastrostomy Feeding Tube.
| Device ID | K092418 |
| 510k Number | K092418 |
| Device Name: | ENTRACARE GASTROSTOMY FEEDING TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ENTRACARE, LLC 11315 STRANGE LINE RD. Lenexa, KS 66215 |
| Contact | Brandon Converse |
| Correspondent | Brandon Converse ENTRACARE, LLC 11315 STRANGE LINE RD. Lenexa, KS 66215 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-06 |
| Decision Date | 2009-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50850009501368 | K092418 | 000 |
| 50850009501221 | K092418 | 000 |
| 50850009501214 | K092418 | 000 |
| 50850009501207 | K092418 | 000 |
| 10850009501193 | K092418 | 000 |
| 50850009501184 | K092418 | 000 |
| 50850009501177 | K092418 | 000 |
| 30850009501425 | K092418 | 000 |
| 30850009501418 | K092418 | 000 |
| 30850009501401 | K092418 | 000 |
| 30850009501395 | K092418 | 000 |
| 30850009501388 | K092418 | 000 |
| 50850009501238 | K092418 | 000 |
| 50850009501245 | K092418 | 000 |
| 50850009501351 | K092418 | 000 |
| 50850009501344 | K092418 | 000 |
| 50850009501337 | K092418 | 000 |
| 50850009501320 | K092418 | 000 |
| 50850009501313 | K092418 | 000 |
| 50850009501306 | K092418 | 000 |
| 50850009501290 | K092418 | 000 |
| 50850009501283 | K092418 | 000 |
| 50850009501276 | K092418 | 000 |
| 50850009501269 | K092418 | 000 |
| 50850009501252 | K092418 | 000 |
| 30850009501371 | K092418 | 000 |