510(k) K894106

DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST by Cd Medical, Inc. — Product Code FIP

K894106 is an FDA 510(k) premarket notification submitted by Cd Medical, Inc. for the device "DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST". The FDA issued a decision of Substantially Equivalent on November 8, 1989. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Cd Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1989
Date Received
June 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type