The following data is part of a premarket notification filed by Evermed, Inc. with the FDA for Non-sterile Peritoneal Access Cathet-.
| Device ID | K830257 |
| 510k Number | K830257 |
| Device Name: | NON-STERILE PERITONEAL ACCESS CATHET- |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | EVERMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-25 |
| Decision Date | 1983-02-24 |