510(k) K013988

MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R by Millipore Corp. — Product Code BSN

K013988 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R". The FDA issued a decision of Substantially Equivalent on April 4, 2002. The device falls under product code BSN (Filter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5130. Millipore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2002
Date Received
December 4, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5130
Review Panel
AN
Submission Type