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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 K023464
Device Name VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
Original Applicant
QUANTEL MEDICAL
342 sunset bay rd.
hot springs,  AR  71913
Original Contact roger w barnes
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/15/2002
Decision Date 01/13/2003
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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