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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 K080382
Device Name SELLAS
Applicant
Dinona Co., Ltd.
13 Red Fox Lane
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Dinona Co., Ltd.
13 Red Fox Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/13/2008
Decision Date 09/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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