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Found 3 results
510(k) Data Aggregation
K Number
K983092Device Name
TRITON HUDSON CHUCK ATTACHMENT
Manufacturer
MEDNEXT, INC.
Date Cleared
1998-11-06
(64 days)
Product Code
HBB
Regulation Number
882.4370Why did this record match?
Applicant Name (Manufacturer) :
MEDNEXT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use during surgical procedures to cut hard tissue, bone and soft tissue and to hold cranial perforators that have a standard Hudson fitting.
Device Description
Hudson Chuck for Mednext TRITON Handpiece
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K Number
K972308Device Name
MEDNEXT 1000 DRILL
Manufacturer
MEDNEXT, INC.
Date Cleared
1997-08-20
(61 days)
Product Code
GEY
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
MEDNEXT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide power to operate various accessories to cut hard tissue, bone, soft tissue.
Device Description
Not Found
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K Number
K970023Device Name
MEDNEXT SURGICAL BUR
Manufacturer
MEDNEXT, INC.
Date Cleared
1997-02-28
(56 days)
Product Code
HWE
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
MEDNEXT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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