510(k) K954349

FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS by Minntech Corp. — Product Code FIP

K954349 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS". The FDA issued a decision of Substantially Equivalent on December 15, 1995. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Minntech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1995
Date Received
September 18, 1995
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