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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
510(k) Number K050933
Device Name FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
Applicant
MEDISURG LTD.
100 WEST FORNANCE ST.
THE FUGO BUILDING
NORRISTOWN,  PA  19401
Applicant Contact RICHARD J FUGO
Correspondent
MEDISURG LTD.
100 WEST FORNANCE ST.
THE FUGO BUILDING
NORRISTOWN,  PA  19401
Correspondent Contact RICHARD J FUGO
Regulation Number886.4100
Classification Product Code
NCR  
Date Received04/14/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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