The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Dialy-nate Set & Dialy-nate Catheter.
| Device ID | K872221 |
| 510k Number | K872221 |
| Device Name: | DIALY-NATE SET & DIALY-NATE CATHETER |
| Classification | Catheter, Peritoneal Dialysis, Single Use |
| Applicant | GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Contact | George E Sinko |
| Correspondent | George E Sinko GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Product Code | FKO |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-09 |
| Decision Date | 1987-10-13 |