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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
Original Applicant
BIOLITEC SIA (LATVIA)
1349 main road
granville,  MA  01034
Original 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
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