510(k) K841403

HEMO-RO WATER PURIFICATION SYS by Millipore Corp. — Product Code FIP

K841403 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "HEMO-RO WATER PURIFICATION SYS". The FDA issued a decision of Substantially Equivalent on July 6, 1984. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Millipore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1984
Date Received
April 3, 1984
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