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FDA 510(k), K111609, BOSTON BAND
FDA 510(k), K111609, BOSTON BAND
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510(K) Number: K111609
Device Name: BOSTON BAND
Manufacturer: BOSTON BRACE INTL., INC.
Device Classification Name: orthosis, cranial
Regulation Number: 882.5970
Classification Product Code: MVA
Date Received: 06/09/2011
Decision Date: 08/22/2011
Regulation Medical Specialty: Neurology
Device Name: BOSTON BAND
Manufacturer: BOSTON BRACE INTL., INC.
Device Classification Name: orthosis, cranial
Regulation Number: 882.5970
Classification Product Code: MVA
Date Received: 06/09/2011
Decision Date: 08/22/2011
Regulation Medical Specialty: Neurology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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