PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS— 510(k) K083451
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K083451 for PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS, Substantially Equivalent on 2009-03-04. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code BSN
- Device class
- Class 2
- Regulation
- 21 CFR 868.5130
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keene, NH, US
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