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510(k) Data Aggregation
K Number
K965205Device Name
TEFGEN - LS
Manufacturer
Date Cleared
1997-04-30
(125 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN CUSTOM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TefGen-LS is an implant material which is intended to be used as a temporary space making barrier over bone or other tissue.
Device Description
TefGen-LS membrane is a 100% PTFE non-absorbable guided tissue membrane. The material is easily trimmed to a variety of shapes as required by specific cases.
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K Number
K964656Device Name
TEFGEN GUIDED TISSUE MEMBRANE
Manufacturer
Date Cleared
1997-02-10
(82 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN CUSTOM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TefGen is an implant material which is intended to be used as a temporary space making barrier over bone or other tissue.
Device Description
TefGen non-reinforced (TefGen-FD) and TefGen reinforced (TefGen-RE) membranes are 100% PTFE non-absorbable guided tissue membranes.
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