The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Epidural Filter, Model 100/386/010, Various Standard And Custom Trays.
| Device ID | K083451 |
| 510k Number | K083451 |
| Device Name: | PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS |
| Classification | Filter, Conduction, Anesthetic |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Cynthia Engelhardt |
| Correspondent | Cynthia Engelhardt SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | BSN |
| CFR Regulation Number | 868.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-21 |
| Decision Date | 2009-03-04 |
| Summary: | summary |