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FDA 510(k), K061228, FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
FDA 510(k), K061228, FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
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510(K) Number: K061228
Device Name: FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
Manufacturer: BRYAN KEROPIAN DDS
Device Classification Name: device, jaw repositioning
Regulation Number: 872.5570
Classification Product Code: LQZ
Date Received: 05/02/2006
Decision Date: 05/26/2006
Regulation Medical Specialty: Dental
Device Name: FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
Manufacturer: BRYAN KEROPIAN DDS
Device Classification Name: device, jaw repositioning
Regulation Number: 872.5570
Classification Product Code: LQZ
Date Received: 05/02/2006
Decision Date: 05/26/2006
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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