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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K860496
Device Name MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY
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
LNK  
Date Received02/10/1986
Decision Date 03/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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