The following data is part of a premarket notification filed by Medigroup, Inc. with the FDA for Flex-neck Arc Catheter.
| Device ID | K070730 |
| 510k Number | K070730 |
| Device Name: | FLEX-NECK ARC CATHETER |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | MEDIGROUP, INC. 14 A STONEHILL RD. Oswego, IL 60543 |
| Contact | John A Navis |
| Correspondent | John A Navis MEDIGROUP, INC. 14 A STONEHILL RD. Oswego, IL 60543 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-15 |
| Decision Date | 2007-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450330231 | K070730 | 000 |
| 10884450170233 | K070730 | 000 |
| 10884450170240 | K070730 | 000 |
| 10884450170318 | K070730 | 000 |
| 10884450170356 | K070730 | 000 |
| 10884450330187 | K070730 | 000 |
| 10884450330194 | K070730 | 000 |
| 10884450330200 | K070730 | 000 |
| 10884450330217 | K070730 | 000 |
| 10884450170226 | K070730 | 000 |