The following data is part of a premarket notification filed by Corpak, Inc. with the FDA for Corpak Medsystems Cruz Catheter For Peritoneal Dialysis.
| Device ID | K964514 |
| 510k Number | K964514 |
| Device Name: | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS |
| Classification | Catheter, Peritoneal Dialysis, Single Use |
| Applicant | CORPAK, INC. 100 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Robert E Booth |
| Correspondent | Robert E Booth CORPAK, INC. 100 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | FKO |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-29 |
| Decision Date | 1998-06-26 |