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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K120437
Device Name TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM
Applicant
Biolitec Sia (Latvia)
1349 Main Rd.
Grandville,  MA  01034
Applicant Contact HARRY HAYES
Correspondent
Biolitec Sia (Latvia)
1349 Main Rd.
Grandville,  MA  01034
Correspondent Contact HARRY HAYES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/13/2012
Decision Date 04/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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