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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K082484
Device Name ACCELAWAVE SYSTEM
Applicant
GENESIS BIOSYSTEMS, INC.
1500 EAGLE COURT
LEWISVILLE,  TX  75057
Applicant Contact BRIAN BUSS
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number878.4810
Classification Product Code
ONF  
Date Received08/28/2008
Decision Date 09/12/2008
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
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