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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 K082928
Device Name STRAIGHT FIRE HOLMIUM LASER FIBER
Applicant
Boston Scientific Corp
100 Boston Scientific Way
Marlborough,  MA  01756
Applicant Contact LAUREN B ANDERSON
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact KACHI C ENYINNA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/01/2008
Decision Date 10/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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