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FDA 510(k), K072862, BOSTON-BAND CRANIAL REMODLING ORTHOSIS
FDA 510(k), K072862, BOSTON-BAND CRANIAL REMODLING ORTHOSIS
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510(K) Number: K072862
Device Name: BOSTON-BAND CRANIAL REMODLING ORTHOSIS
Manufacturer: BOSTON BRACE INTL., INC.
Device Classification Name: orthosis, cranial, laser scan
Regulation Number: 882.5970
Classification Product Code: OAN
Date Received: 10/05/2007
Decision Date: 01/22/2008
Regulation Medical Specialty: Neurology
Device Name: BOSTON-BAND CRANIAL REMODLING ORTHOSIS
Manufacturer: BOSTON BRACE INTL., INC.
Device Classification Name: orthosis, cranial, laser scan
Regulation Number: 882.5970
Classification Product Code: OAN
Date Received: 10/05/2007
Decision Date: 01/22/2008
Regulation Medical Specialty: Neurology
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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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