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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K864387
Device Name LUXTEC FIBEROPTIC CABLES
Applicant
Luxtec Corp.
P.O. Box 225, Rte 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Applicant Contact THOMAS WILK
Correspondent
Luxtec Corp.
P.O. Box 225, Rte 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Correspondent Contact THOMAS WILK
Regulation Number874.4350
Classification Product Code
EQH  
Date Received11/05/1986
Decision Date 05/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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