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510(k) Data Aggregation
K Number
K020959Device Name
GLO-SPEC I, II AND III
Manufacturer
Date Cleared
2002-06-19
(86 days)
Product Code
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
SOL WEISS MD INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended uses are interconnection of devices for transmission of light, hold suction tubes and instruments.
Device Description
The devices are made of injected molded parts. Does not require assembly (simple product). Has vents to allow heat to escape. No contact with body surfaces. Has interlocking cone for device attachment. The device is for single use only.
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K Number
K013817Device Name
GLO-SPEC
Manufacturer
Date Cleared
2001-12-21
(35 days)
Product Code
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
SOL WEISS MD INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use is interconnection of devices for transmission of light.
The intended use is to illuminate area of view.
The intended use is the interconnection of devices for transmission of light.
Device Description
Not Found
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K Number
K012859Device Name
NU-SPEC D
Manufacturer
Date Cleared
2001-10-26
(63 days)
Product Code
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
SOL WEISS MD INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is to be used for exposing the interior of the vagina.
Device Description
- The device is made of injected molded parts .
- The device assembly includes a window trap for pins to snap together ●
- The instrument has levels in the windows to lock positions as desired . by the expanding vertical blades
- The lateral blade protectors act to prevent lateral walls from cascading ● into view area.
- Lateral protector blades are same thickness of vertical blades thus act as rigid barriers
- Lateral protector blades conform with the design of vertical blade that . provide rigid conforming structures that allows smooth unchanged entrance
The device once snapped together do not require any further assembly
- The device is for single use only
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