The following data is part of a premarket notification filed by Medigroup, Inc. with the FDA for Flex-neck Exxtended Peritoneal Dialysis Catheter And Accessories, Model Cf-5560.
| Device ID | K071167 |
| 510k Number | K071167 |
| Device Name: | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | MEDIGROUP, INC. 14 A STONEHILL RD. Oswego, IL 60543 -9400 |
| Contact | John A Navis |
| Correspondent | John A Navis MEDIGROUP, INC. 14 A STONEHILL RD. Oswego, IL 60543 -9400 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-26 |
| Decision Date | 2007-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450334120 | K071167 | 000 |
| 10884450330248 | K071167 | 000 |
| 20884450276994 | K071167 | 000 |
| 20884450276987 | K071167 | 000 |
| 20884450252240 | K071167 | 000 |
| 20884450170254 | K071167 | 000 |