510(k) K983126

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

K983126 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS". The FDA issued a decision of Substantially Equivalent on March 8, 1999. 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
March 8, 1999
Date Received
September 8, 1998
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