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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 K853620
Device Name MODEL XA-50 - CO2 SURGICAL LASER
Applicant
Xanar, Inc.
2868 Janitell Rd.
Colorado Springs,  CO  80906
Applicant Contact DAVID A ENSOR
Correspondent
Xanar, Inc.
2868 Janitell Rd.
Colorado Springs,  CO  80906
Correspondent Contact DAVID A ENSOR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/29/1985
Decision Date 01/24/1986
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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