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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
Applicant Contact harry hayes
Correspondent
BIOLITEC MEDICAL DEVICES, INC
1349 main road
granville,  MA  01034
Correspondent Contact harry hayes
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/19/2011
Decision Date 01/20/2012
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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