The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Capd Safelock Transfer Set W/pre-filled Connector.
Device ID | K904806 |
510k Number | K904806 |
Device Name: | CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR |
Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
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 | KDJ |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-24 |
Decision Date | 1991-01-11 |