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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 K100746
Device Name FIBER ONE
Original Applicant
AMERICAN MEDICAL SYSTEMS
155-a moffett park drive
suite 210
sunnyvale,  CA  94089
Original Contact darlene crockett-billig
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/16/2010
Decision Date 06/11/2010
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
Recalls CDRH Recalls
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