MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
FDA 510(k) clearance K013988 · decided 2002-04-04
Clearance details
- K-number
- K013988
- Device name
- MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
- Applicant
- Millipore Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-04
- Decision date
- 2002-04-04
- Days to decision
- 121 days
- Clearance type
- Special
- Product code
- BSN
- Device class
- 2
- Regulation number
- 868.5130
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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| MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (K963717) | Millipore Corp. | 1997-06-10 |
| SYRINGEFILTER (K960928) | Arbor Technologies, Inc. | 1997-04-04 |
| ANESTHESIA CONDUCTION FILTER (K902666) | Arbor Technologies, Inc. | 1991-04-23 |
| FILTER TUBE (K780519) | Jelco Laboratories | 1978-05-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THERAPEUTIC APHERESIS SYSTEM (P850092) | Millipore Corp. | 1986-11-18 |