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510(k) Data Aggregation
K Number
K990894Device Name
ETB TROCAR SYSTEM
Manufacturer
Date Cleared
1999-05-19
(62 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
THE ALTOMEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Telesopes (laparoscopy): Telescopes are used to illuminal cavity) by means of an external light source and to transmit an optical image from inside the cavity.
Device Description
Not Found
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K Number
K972298Device Name
ETB TELESCOPE W/WORKING CHANNEL FOR SEPS
Manufacturer
Date Cleared
1998-01-30
(225 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
THE ALTOMEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SEPS Videoscope is a telescope with working channel and outer sheath for the endoscopic sufascial dissection of the venea perforantes and fasciotomy. The instrument is introduced into a natural or artificial body cavities to illuminate them and to transmit an optical image from inside the cavity. The working channel allows to introduce instruments into the cavity.
Device Description
The SEPS Videoscope is a telescope with working channel and outer sheath.
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