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510(k) Data Aggregation
K Number
K961536Device Name
FLEXSCOPE
Manufacturer
MATRIX MEDICA, INC.
Date Cleared
1996-09-18
(149 days)
Product Code
GDB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MATRIX MEDICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FlexScope is intended to be used for visualization of tissue in The general surgical applications.
Device Description
The FlexScope™ is a flexible deflectable endoscope intended to allow physicians to visualize tissue in body cavities and through natural body orifices. The device is designed to be advanced to the site of interest through a cannula or trocar or may be used in an open procedure. The device will is available in various diameters.
The method of construction and materials used for these flexible fiber optic endoscopes are substantially equivalent to previous endoscope products.
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K Number
K923693Device Name
KLORMAN
Manufacturer
MATRIX MEDICA, INC.
Date Cleared
1996-01-23
(1279 days)
Product Code
LRJ
Regulation Number
880.6890Why did this record match?
Applicant Name (Manufacturer) :
MATRIX MEDICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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