The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius Pd+ Exchange Device.
| Device ID | K915634 |
| 510k Number | K915634 |
| Device Name: | FRESENIUS PD+ EXCHANGE DEVICE |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Tom Folden |
| Correspondent | Tom Folden FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-17 |
| Decision Date | 1993-07-01 |