The following data is part of a premarket notification filed by Medigroup, Inc. with the FDA for Peritoneal Dialysis Catheter Connector.
| Device ID | K974570 |
| 510k Number | K974570 |
| Device Name: | PERITONEAL DIALYSIS CATHETER CONNECTOR |
| Classification | Catheter, Peritoneal Dialysis, Single Use |
| Applicant | MEDIGROUP, INC. 615 ENTERPRISE ST. Aurora, IL 60504 -8138 |
| Contact | John Navis |
| Correspondent | John Navis MEDIGROUP, INC. 615 ENTERPRISE ST. Aurora, IL 60504 -8138 |
| Product Code | FKO |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-08 |
| Decision Date | 1998-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450170028 | K974570 | 000 |