FDA 510(k), K984534, PRECLUDE ACUSEAL DURA SUBSTITUTE
FDA 510(k), K984534, PRECLUDE ACUSEAL DURA SUBSTITUTE
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510(K) Number: K984534
Device Name: PRECLUDE ACUSEAL DURA SUBSTITUTE
Manufacturer: W.L. GORE & ASSOCIATES,INC
Device Classification Name: dura substitute
Regulation Number: 882.5910
Classification Product Code: GXQ
Date Received: 12/21/1998
Decision Date: 03/15/1999
Regulation Medical Specialty: Neurology
Device Name: PRECLUDE ACUSEAL DURA SUBSTITUTE
Manufacturer: W.L. GORE & ASSOCIATES,INC
Device Classification Name: dura substitute
Regulation Number: 882.5910
Classification Product Code: GXQ
Date Received: 12/21/1998
Decision Date: 03/15/1999
Regulation Medical Specialty: Neurology