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FDA 510(k), K113088, HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
FDA 510(k), K113088, HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
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510(K) Number: K113088
Device Name: HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
Manufacturer: INNERSPACE, INC
Device Classification Name: device, monitoring, intracranial pressure
Regulation Number: 882.1620
Classification Product Code: GWM
Date Received: 10/19/2011
Decision Date: 05/02/2012
Regulation Medical Specialty: Neurology
Device Name: HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
Manufacturer: INNERSPACE, INC
Device Classification Name: device, monitoring, intracranial pressure
Regulation Number: 882.1620
Classification Product Code: GWM
Date Received: 10/19/2011
Decision Date: 05/02/2012
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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