The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for Drake Willock System 1000 Dialysate Delivery Syst.
Device ID | K910215 |
510k Number | K910215 |
Device Name: | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST |
Classification | System, Dialysate Delivery, Single Patient |
Applicant | CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Gordon W Robertson |
Correspondent | Gordon W Robertson CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | FKP |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-17 |
Decision Date | 1991-04-09 |