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510(k) Data Aggregation
K Number
K132039Device Name
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
Manufacturer
JEDMED INSTRUMENT CO.
Date Cleared
2014-02-21
(234 days)
Product Code
EQN
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
JEDMED INSTRUMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JEDMED's Ergo-Flex EF-N and EF-N Slim Laryngo-Nasopharyngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal cords.
Device Description
This flexible scope is designed with the insertion tube with its bendable distal tip, the handle, the eyepiece and the focus ring. The handle incorporates the control lever to bend the distal tip and the connectors for the leakage tester and the fiber optic light-guide cable.
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K Number
K021750Device Name
LID CHAIN EYELID WEIGHTS
Manufacturer
JEDMED INSTRUMENT CO.
Date Cleared
2003-01-27
(244 days)
Product Code
MML
Regulation Number
886.5700Why did this record match?
Applicant Name (Manufacturer) :
JEDMED INSTRUMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Restoration of dynamic lid closure in paralytic lagophthalmos due to facial nerve paralysis
Device Description
Lid Chain Eyelid Weight Implant
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