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FDA 510(k), K091035, FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
FDA 510(k), K091035, FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
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510(K) Number: K091035
Device Name: FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
Manufacturer: BRYAN KEROPIAN DDS
Device Classification Name: Device, Jaw Repositioning
Regulation Number: 872.5570
Classification Product Code: LQZ
Date Received: 04/10/2009
Decision Date: 06/24/2009
Regulation Medical Specialty: Dental
Device Name: FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
Manufacturer: BRYAN KEROPIAN DDS
Device Classification Name: Device, Jaw Repositioning
Regulation Number: 872.5570
Classification Product Code: LQZ
Date Received: 04/10/2009
Decision Date: 06/24/2009
Regulation Medical Specialty: Dental
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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