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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 K113489
Device Name ORION
Original Applicant
ASCLEPION LASER TECHNOLOGIES GMBH
bruesseler str. 10
jena,  GM 07747
Original Contact antje katzer
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/23/2011
Decision Date 07/27/2012
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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