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FDA 510(k), K111776, DELTAVIEW MODEL 2.1
FDA 510(k), K111776, DELTAVIEW MODEL 2.1
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510(K) Number: K111776
Device Name: DELTAVIEW MODEL 2.1
Manufacturer: JENNIFER V BUTSCH
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 06/23/2011
Decision Date: 12/28/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: DELTAVIEW MODEL 2.1
Manufacturer: JENNIFER V BUTSCH
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 06/23/2011
Decision Date: 12/28/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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