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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 K850804
Device Name CO 2 SURGICAL LASER SYSTEM NA-30
Applicant
Xanar, Inc.
2868 Janitell Rd.
Colorado Springs,  CO  80906
Applicant Contact LEO J NOLAN
Correspondent
Xanar, Inc.
2868 Janitell Rd.
Colorado Springs,  CO  80906
Correspondent Contact LEO J NOLAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/27/1985
Decision Date 08/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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