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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 K142286
Device Name NS3000 Holmium Laser System
Applicant
New Star Lasers, Inc.
9085 Foothills Blvd.
Roseville,  CA  95747
Applicant Contact Natalie Vollrath
Correspondent
Buckman Company, Inc.
2800 Pleasant Hill Rd., Suite 175
Pleasant Hill,  CA  94523
Correspondent Contact Pamela M. Buckman
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/18/2014
Decision Date 10/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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