AEU-14CF EXPENDITION
FDA 510(k) clearance K050201 · decided 2005-03-18
Clearance details
- K-number
- K050201
- Device name
- AEU-14CF EXPENDITION
- Applicant
- Aseptico, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-28
- Decision date
- 2005-03-18
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- EIA
- Device class
- 1
- Regulation number
- 872.6640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Woodinville, WA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.