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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 K073022
Device Name CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
Original Applicant
675 pine street
elgin,  IL  60123
Original Contact jill creasy
Regulation Number878.4810
Classification Product Code
Subsequent Product Code
Date Received10/26/2007
Decision Date 10/01/2008
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