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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K864384
Device Name LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS
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
GAD  
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
Predetermined Change
Control Plan Authorized		 No
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