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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 K031805
Device Name BLU-U, MODEL 4170
Applicant
Dusa Pharmaceuticals, Inc.
25 Upton Dr.
Wilmington,  MA  01887
Applicant Contact SCOTT LUNDAHL
Correspondent
Dusa Pharmaceuticals, Inc.
25 Upton Dr.
Wilmington,  MA  01887
Correspondent Contact SCOTT LUNDAHL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/11/2003
Decision Date 09/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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