The following data is part of a premarket notification filed by Fresenius Medical Care with the FDA for \resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector.
| Device ID | K022536 |
| 510k Number | K022536 |
| Device Name: | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | FRESENIUS MEDICAL CARE 95 HAYDEN AVE. Lexington, MA 02420 |
| Contact | Art Eilinsfeld |
| Correspondent | Art Eilinsfeld FRESENIUS MEDICAL CARE 95 HAYDEN AVE. Lexington, MA 02420 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-01 |
| Decision Date | 2002-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100313 | K022536 | 000 |