The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Capd Staged Connector.
Device ID | K845041 |
510k Number | K845041 |
Device Name: | CAPD STAGED CONNECTOR |
Classification | Catheter, Peritoneal Dialysis, Single Use |
Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Contact | Frederick Gustafson |
Correspondent | Frederick Gustafson ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Product Code | FKO |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-28 |
Decision Date | 1985-02-21 |