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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, fiberoptic
510(k) Number K864380
Device Name LUTEX HEADLIGHT SYSTEMS
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 Number878.4580
Classification Product Code
FST  
Date Received11/05/1986
Decision Date 11/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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