The following data is part of a premarket notification filed by Cair Lgl with the FDA for Nasogastric Feeding Tubes - Enfit Port - Pvc.
| Device ID | K213258 |
| 510k Number | K213258 |
| Device Name: | Nasogastric Feeding Tubes - ENFit Port - PVC |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Cair Lgl Parc Tertiaire De Bois Dieu, 1 Allee Des Chevreuils Lissieu, FR 69380 |
| Contact | Irving L. Wiesen |
| Correspondent | Glenn Brunner Vesco Medical 1039 Kingsmill Parkway Columbus, OH 43229 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 23661657052333 | K213258 | 000 |
| 23661657052234 | K213258 | 000 |
| 23661657052241 | K213258 | 000 |
| 23661657052258 | K213258 | 000 |
| 13661657052268 | K213258 | 000 |
| 23661657052272 | K213258 | 000 |
| 13661657052282 | K213258 | 000 |
| 13661657052299 | K213258 | 000 |
| 23661657052302 | K213258 | 000 |
| 23661657052319 | K213258 | 000 |
| 23661657052326 | K213258 | 000 |
| 13661657052220 | K213258 | 000 |