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510(k) Data Aggregation
K Number
K031788Device Name
PATHFINDER
Manufacturer
Date Cleared
2004-09-02
(450 days)
Product Code
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
MASSIE RESEARCH LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For general ophthalmic imaging, visualization, and fluorescein angiography including anterior and posterior segments of the eye.
Device Description
Not Found
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K Number
K001275Device Name
RETCAM II
Manufacturer
Date Cleared
2000-07-13
(84 days)
Product Code
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
MASSIE RESEARCH LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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