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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light source, fiberoptic, routine
510(k) Number K081477
Device Name LUXTEC MLX LIGHT SOURCE
Applicant
INTEGRA LUXTEC, INC.
99 HARTWELL ST.
WEST BOYLSTON,  MA  01583
Applicant Contact RITA WADLEIGH
Correspondent
INTEGRA LUXTEC, INC.
99 HARTWELL ST.
WEST BOYLSTON,  MA  01583
Correspondent Contact RITA WADLEIGH
Regulation Number876.1500
Classification Product Code
FCW  
Date Received05/27/2008
Decision Date 06/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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