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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 K083476
Device Name NOVEON MODEL LS1100-03
Applicant
Nomir Medical Technologies, Inc.
307 Waverley Oaks Rd.
Suite 109
Waltham,  MA  02452
Applicant Contact RICHARD F BURTT
Correspondent
Nomir Medical Technologies, Inc.
307 Waverley Oaks Rd.
Suite 109
Waltham,  MA  02452
Correspondent Contact RICHARD F BURTT
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/24/2008
Decision Date 12/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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