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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 W. Fornance St.
The Fugo Bldg.
Norristown,  PA  19401
Applicant Contact RICHARD J FUGO
Correspondent
Medisurg , Ltd.
100 W. Fornance St.
The Fugo Bldg.
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
Predetermined Change
Control Plan Authorized		 No
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