AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV
FDA 510(k) clearance K043497 · decided 2005-03-21
Clearance details
- K-number
- K043497
- Device name
- AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV
- Applicant
- J. Morita USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-17
- Decision date
- 2005-03-21
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.