FDA 510(k), K161138, St. Louis Band

FDA 510(k), K161138, St. Louis Band

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510(K) Number: K161138
Device Name: St. Louis Band
Manufacturer: DAVID C. KERR
Device Classification Name: Orthosis, Cranial, Laser Scan
Regulation Number: OAN
Classification Product Code: 04/22/2016
Date Received: 07/20/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology

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