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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K090724
Device Name OR-LIGHT
Applicant
YPERION TECHNOLOGY
2 RUE BEETHOVEN
PARIS,  FR 75016
Applicant Contact PASCAL DANET
Correspondent
YPERION TECHNOLOGY
2 RUE BEETHOVEN
PARIS,  FR 75016
Correspondent Contact PASCAL DANET
Regulation Number878.4810
Classification Product Code
ONF  
Date Received03/19/2009
Decision Date 10/07/2009
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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