The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for Drake Willock Reverse Osmosis Water Treatment Syst.
Device ID | K894106 |
510k Number | K894106 |
Device Name: | DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST |
Classification | Subsystem, Water Purification |
Applicant | CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Marian D Harding |
Correspondent | Marian D Harding CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-09 |
Decision Date | 1989-11-08 |