510(k) K013988
- Device
- MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
- Applicant
- MILLIPORE CORP.
- 510(k) number
- K013988
- Product code
- BSN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-04-04
- Date received
- 2001-12-04
- Regulation
- 868.5130
- Classification name
- Filter, Conduction, Anesthetic
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS BORROWS
- Address
- 80 Ashby Rd. Bedford MA US 01730 01730
FDA Registration Numbers#
- 9611612
- 3002807314
- 8020892
- 9612003
- 3010321647
- 3008717264
- 3012307300
- 3007441619
- 3010173425
- 3011237704
- 1319639
- 3005941719
- 3004417597
- 3012542015
- 9617604
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BSN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 | PAJUNK GmbH Medizintechnologie | 2019-06-17 |
| K133004 | VENTED MILLEX -GV, CATHIVEX -GV | Merck Millipore , Ltd. | 2014-03-27 |
| K083451 | PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS | Smiths Medical Asd, Inc. | 2009-03-04 |
| K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | Millipore Corp. | 2003-01-17 |
| K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | Millipore Corp. | 1997-06-10 |
| K960928 | SYRINGEFILTER | Arbor Technologies, Inc. | 1997-04-04 |
| K902666 | ANESTHESIA CONDUCTION FILTER | Arbor Technologies, Inc. | 1991-04-23 |
| K780519 | FILTER TUBE | Jelco Laboratories | 1978-05-09 |
Legacy Summary#
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FDA Review#
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