The following data is part of a premarket notification filed by Medigroup, Inc. with the FDA for Flex-neck Pd Catheter, Infant.
| Device ID | K031351 |
| 510k Number | K031351 |
| Device Name: | FLEX-NECK PD CATHETER, INFANT |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | MEDIGROUP, INC. 505 WESTON RIDGE DR. Naperville, IL 60563 -3932 |
| Contact | John A Navis |
| Correspondent | John A Navis MEDIGROUP, INC. 505 WESTON RIDGE DR. Naperville, IL 60563 -3932 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-29 |
| Decision Date | 2003-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450375000 | K031351 | 000 |
| 20884450170261 | K031351 | 000 |
| 10884450170271 | K031351 | 000 |
| 10884450170288 | K031351 | 000 |
| 10884450305857 | K031351 | 000 |
| 10884450305871 | K031351 | 000 |
| 10884450330064 | K031351 | 000 |
| 10884450330071 | K031351 | 000 |
| 10884450330088 | K031351 | 000 |
| 20884450170056 | K031351 | 000 |