510(k) K013988
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