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510(k) Data Aggregation
K Number
K111845Device Name
THE ESPINER SAC OR E SAC
Manufacturer
ESPINER MEDICAL LIMITED
Date Cleared
2011-09-26
(89 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ESPINER MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.
Device Description
The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.
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