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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 K900463
Device Name LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS
Applicant
Ximed Medical Systems
2855 Kifer Rd.
Santa Clara,  CA  95050
Applicant Contact DESAI
Correspondent
Ximed Medical Systems
2855 Kifer Rd.
Santa Clara,  CA  95050
Correspondent Contact DESAI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/31/1990
Decision Date 03/22/1990
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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