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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 K001498
Device Name THE FUGO BLADE
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 Received05/15/2000
Decision Date 08/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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