The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for Drake Willock Central Dialysate Delivery System.
| Device ID | K862304 |
| 510k Number | K862304 |
| Device Name: | DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Albert E Jarvis,phd |
| Correspondent | Albert E Jarvis,phd CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-17 |
| Decision Date | 1986-09-09 |