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510(k) Data Aggregation
K Number
K073053Device Name
COLPO-MASTER
Manufacturer
Date Cleared
2007-11-15
(16 days)
Product Code
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
**UNITED PRODUCTS **& INSTRUMENTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UNICO Colpo-Master Colposcope is indicated for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy
Device Description
The Colposcope consists of three main assemblies: Microscope head and lens; Stand; and Illuminator. . The microssope 200m head magnifies the arca of the human body to be observed by a physician. It works like a "tclcscope" and the closest point is more than 300mm away from the body part. The microscope head and lens are made of optical glass, brass, stecl, and aluminum.
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