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 |