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510(k) Data Aggregation
K Number
K962032Device Name
KARL STORZ TWIN TRANSILLUMINATOR
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
1996-07-05
(42 days)
Product Code
MQW
Regulation Number
874.4350Why did this record match?
Product Code :
MQW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures.
Device Description
The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are manual, reusable, nonsterile medical devices. The body contact materials of these devices have a long history of biocompatibility with medical devices.
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