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510(k) Data Aggregation
K Number
K974540Device Name
SIS HERNIA REPAIR DEVICE
Manufacturer
SENTRON MEDICAL, INC.
Date Cleared
1998-05-20
(168 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SENTRON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.
Device Description
The SIS Hernia Repair Device is intended to be used for reconstructing and supporting soft tissues such as fo the repair of a hernia or body wall defect. The device is supplied sterile and is intended for one-time use. The material comprising the device has undergone appropriate biocompatibility and performance testing that provides reasonable assurance of safety and efficacy for its intended use.
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