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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, Floor Standing
510(k) Number K930711
Device Name TRI*STAR
Applicant
Light Technology Systems
16760 Stagg St., #211
Van Nuys,  CA  91406
Applicant Contact HOWARD A WANIGA
Correspondent
Light Technology Systems
16760 Stagg St., #211
Van Nuys,  CA  91406
Correspondent Contact HOWARD A WANIGA
Regulation Number878.4580
Classification Product Code
FSS  
Date Received02/11/1993
Decision Date 07/30/1993
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
Recalls CDRH Recalls
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