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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 K021550
Device Name LUMENIS SELECTA DUET
Applicant
Ellex Medical Pty, Ltd.
7138 Shady Oak Rd.
Minneapolis,  MN  55344
Applicant Contact BILL SWAIM
Correspondent
Ellex Medical Pty, Ltd.
7138 Shady Oak Rd.
Minneapolis,  MN  55344
Correspondent Contact BILL SWAIM
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/13/2002
Decision Date 08/09/2002
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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