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FDA 510(k), K180109, STARband, STARlight, St. Louis Band
FDA 510(k), K180109, STARband, STARlight, St. Louis Band
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$49.00 USD
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510(K) Number: K180109
Device Name: STARband, STARlight, St. Louis Band
Manufacturer: David C. Kerr
Device Classification Name: Orthosis, Cranial, Laser Scan
Regulation Number: OAN
Classification Product Code: KXA
Date Received: 01/16/2018
Decision Date: 03/01/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: STARband, STARlight, St. Louis Band
Manufacturer: David C. Kerr
Device Classification Name: Orthosis, Cranial, Laser Scan
Regulation Number: OAN
Classification Product Code: KXA
Date Received: 01/16/2018
Decision Date: 03/01/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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