The following data is part of a premarket notification filed by Janin Group, Inc. with the FDA for Medigroup Catheter Extender/repair Kit.
| Device ID | K012502 |
| 510k Number | K012502 |
| Device Name: | MEDIGROUP CATHETER EXTENDER/REPAIR KIT |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | JANIN GROUP, INC. 505 WESTON RIDGE DR. Naperville, IL 60563 -3932 |
| Contact | John A Navis |
| Correspondent | John A Navis JANIN GROUP, 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 | 2001-08-03 |
| Decision Date | 2002-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450170063 | K012502 | 000 |