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510(k) Data Aggregation
K Number
K033457Device Name
M2 COMPATIBLE MICROKERATOME BLADE
Manufacturer
Date Cleared
2004-05-25
(208 days)
Product Code
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
MICRO SPECIALTIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191
Device Description
The MICROspecialties, Inc. disposable M2 compatible Microkeratome blade is a replacement stainless steel blade for the Moria M2 Microkeratome blade. Both blades are made of 400 series stainless steel and they are packaged and shipped using the same methods. Both blades are single-use, sterile, and disposable blades.
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