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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K081578
Device Name ACCELA SYSTEM
Applicant
Genesis Biosystems, Inc.
1500 Eagle Court
Lewisville,  TX  75057
Applicant Contact STEPHEN J MACDONALD
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/05/2008
Decision Date 06/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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