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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 K112442
Device Name RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
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
Correspodent Contact harry hayes
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/24/2011
Decision Date 09/30/2011
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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