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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ent microsurgical carbon-dioxide
510(k) Number K841860
Device Name CO2 SURGICAL LASER SYSTEM XML-10
Applicant
XANAR, INC.
2868 JANITELL RD.
COLORADO SPRINGS,  CO  80906
Applicant Contact DALTON
Correspondent
XANAR, INC.
2868 JANITELL RD.
COLORADO SPRINGS,  CO  80906
Correspondent Contact DALTON
Regulation Number874.4500
Classification Product Code
EWG  
Date Received05/04/1984
Decision Date 11/08/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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