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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 K093691
Device Name ACCUMAX
Applicant
Boston Scientific Corp
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact NICHOLE RIEK
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/30/2009
Decision Date 12/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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