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510(k) Data Aggregation
K Number
K020079Device Name
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
Manufacturer
BLADE WORKS, INC.
Date Cleared
2002-04-19
(99 days)
Product Code
HNO
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
BLADE WORKS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blade Works 7061 microkeratome blades are to be used as replacement blades for the Moria LSK-One microkeratome, to perform lamellar keratectomy procedures.
Device Description
Blade Works Microkeratome Blade, Model 7061
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K Number
K993225Device Name
BLADEWORKS MICROKERATOME BLADE
Manufacturer
BLADE WORKS, INC.
Date Cleared
2000-03-20
(175 days)
Product Code
HNO
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
BLADE WORKS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bladeworks BW 9000 Microkeratorne Blade, in conjunction with the Chiron ACS microkeratome, and the Bladeworks BW 1011 Microkeratome Blade, in conjunction with the Chiron Hansatome microkerutome, is used to perform lamellar keratoplasty procedures.
Device Description
Bladeworks Microkeratome Blade
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K Number
K993591Device Name
BLADEWORKS DISPOSABLE ALK TUBING
Manufacturer
BLADE WORKS, INC.
Date Cleared
1999-12-28
(67 days)
Product Code
KYG
Regulation Number
886.4360Why did this record match?
Applicant Name (Manufacturer) :
BLADE WORKS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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