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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 K113709
Device Name MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
Applicant
BIOLITEC MEDICAL DEVICES, INC
1349 main road
granville,  MA  01034
Contact harry hayes
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/19/2011
Decision Date 01/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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