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510(k) Data Aggregation
K Number
K033395Device Name
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
Manufacturer
Codman & Shurtleff, Inc.
Date Cleared
2004-02-25
(125 days)
Product Code
GXO, GXQ
Regulation Number
882.5900Why did this record match?
Product Code :
GXO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODMAN Dural Graft Implant is intended for use in procedures where the repair or substitute of the patient's dura mater is needed.
Device Description
The CODMAN Dural Graft Implant is a collagen sponge manufactured from processed bovine tendons. It is a sterile, absorbable implant intended for the repair of the patient's dura matter. The CODMAN Dural Graft Implant is designed to be a sutureless, onlay graft, but tensionless sutures can be used if preferred by the surgeon.
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K Number
K961802Device Name
PRECLUDE SYNBLOC MEMBRANE
Manufacturer
W.L. GORE & ASSOCIATES,INC
Date Cleared
1996-07-31
(83 days)
Product Code
GXO
Regulation Number
882.5900Why did this record match?
Product Code :
GXO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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