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FDA 510(k), K140023, ELEVATION
FDA 510(k), K140023, ELEVATION
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510(K) Number: K140023
Device Name: ELEVATION
Manufacturer: EDWARD A KROLL
Device Classification Name: Wheelchair, Mechanical
Regulation Number: IOR
Classification Product Code: KXA
Date Received: 01/06/2014
Decision Date: 10/16/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Device Name: ELEVATION
Manufacturer: EDWARD A KROLL
Device Classification Name: Wheelchair, Mechanical
Regulation Number: IOR
Classification Product Code: KXA
Date Received: 01/06/2014
Decision Date: 10/16/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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