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FDA 510(k), K120600, DURAGEN SECURE DURAL REGNERATION MATRIX
FDA 510(k), K120600, DURAGEN SECURE DURAL REGNERATION MATRIX
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510(K) Number: K120600
Device Name: DURAGEN SECURE DURAL REGNERATION MATRIX
Manufacturer: INTEGRA LIFESCIENCES
Device Classification Name: Dura Substitute
Regulation Number: 882.5910
Classification Product Code: GXQ
Date Received: 02/28/2012
Decision Date: 06/15/2012
Regulation Medical Specialty: Neurology
Device Name: DURAGEN SECURE DURAL REGNERATION MATRIX
Manufacturer: INTEGRA LIFESCIENCES
Device Classification Name: Dura Substitute
Regulation Number: 882.5910
Classification Product Code: GXQ
Date Received: 02/28/2012
Decision Date: 06/15/2012
Regulation Medical Specialty: Neurology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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