510(k) K992786

PURE WATER, INC.'S WATER PURIFICATION SYSTEMS by Pure Water, Inc. — Product Code FIP

K992786 is an FDA 510(k) premarket notification submitted by Pure Water, Inc. for the device "PURE WATER, INC.'S WATER PURIFICATION SYSTEMS". The FDA issued a decision of Substantially Equivalent on January 24, 2000. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Pure Water, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2000
Date Received
August 19, 1999
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