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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 K890716
Device Name LUXTEC ACO SERIES 4000 LIGHT SOURCE
Applicant
Luxtec Corp.
P.O. Box 225, Rte. 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Applicant Contact BRUCE K PACKARD
Correspondent
Luxtec Corp.
P.O. Box 225, Rte. 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Correspondent Contact BRUCE K PACKARD
Regulation Number876.1500
Classification Product Code
FCW  
Date Received02/13/1989
Decision Date 04/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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