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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name loupe, diagnostic/surgical
510(k) Number K864386
Device Name LUXTEC LOUPES FOR SURGICAL VISION
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 Number878.4800
Classification Product Code
FSP  
Date Received11/05/1986
Decision Date 11/17/1986
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
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