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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 K960475
Device Name MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM
Applicant
Luxar Corp.
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact JONATHAN S KAHN
Correspondent
Luxar Corp.
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/01/1996
Decision Date 04/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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