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510(k) Data Aggregation
K Number
K970917Device Name
SOLOS 10MM OPERATING LAPAROSCOPE
Manufacturer
Date Cleared
1997-06-10
(90 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
WOODBINE OPTICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
to allow surgeons to view the interior cavities of the human body under direct vision through the scope for the purpose of performing surgery by general surgeons and thoracic surgeons.
Device Description
Solos 10mm Operating Laparoscope
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K Number
K970056Device Name
SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES
Manufacturer
Date Cleared
1997-01-28
(21 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
WOODBINE OPTICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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