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Found 6 results
510(k) Data Aggregation
K Number
K082110Device Name
DUAL SYRINGE HOLDER
Manufacturer
SURGIN SURGICAL INSTRUMENTATION, INC.
Date Cleared
2009-06-17
(324 days)
Product Code
FMG
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
SURGIN SURGICAL INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K033236Device Name
PRIZM KERATOME BLADE, MODEL MK8512M2
Manufacturer
SURGIN SURGICAL INSTRUMENTATION, INC.
Date Cleared
2004-03-26
(172 days)
Product Code
HNO
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
SURGIN SURGICAL INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prizm Keratome Blade VII is to be used as a replacement blade for the blade in the non-disposable Moria M2 keratome for lamellar resection of the corner.
Device Description
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K Number
K033182Device Name
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
Manufacturer
SURGIN SURGICAL INSTRUMENTATION, INC.
Date Cleared
2004-01-30
(121 days)
Product Code
HNO
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
SURGIN SURGICAL INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SURGIN'S PRIZM BLADES ARE DESIGNATED AS REPLACEMENT BLADES FOR THE "BECTON DICKINSON BD - 3000 MICRO SURGICAL SYSTEM", TO BE USED FOR LAMELLAR RESECTION OF THE CORNEA
Device Description
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K Number
K011195Device Name
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
Manufacturer
SURGIN SURGICAL INSTRUMENTATION, INC.
Date Cleared
2001-11-06
(201 days)
Product Code
HNO
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
SURGIN SURGICAL INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994015Device Name
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
Manufacturer
SURGIN SURGICAL INSTRUMENTATION, INC.
Date Cleared
2000-03-15
(110 days)
Product Code
HNO
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
SURGIN SURGICAL INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgin Inc. AccuBlade(ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratomo and Chiron Hansatome microkeratome for lamellar resection of the cornea
Device Description
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K Number
K980849Device Name
SURGIN KIT
Manufacturer
SURGIN SURGICAL INSTRUMENTATION, INC.
Date Cleared
1998-07-09
(154 days)
Product Code
MSR
Regulation Number
886.4150Why did this record match?
Applicant Name (Manufacturer) :
SURGIN SURGICAL INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.
Device Description
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