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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 K100678
Device Name SUPRA SCAN DELIVERY SYSTEM
Applicant
Quantel Medical
21 Rue Newton; Zi Le Brezet
Clermont Ferrand,  FR 63039
Applicant Contact PATRICK QUERO
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/10/2010
Decision Date 07/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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