AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES
FDA 510(k) clearance K090379 · decided 2010-05-26
Clearance details
- K-number
- K090379
- Device name
- AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES
- Applicant
- Avita Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-02-17
- Decision date
- 2010-05-26
- Days to decision
- 463 days
- Clearance type
- Traditional
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Flagstaff, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.