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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K091581
Device Name SUPRA 577.Y LASER
Applicant
QUANTEL MEDICAL
21 RUE NEWTON - ZONE DU BREZET
CLERMONT-FERRAND,  FR 63039
Applicant Contact PATRICK QUERO
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/02/2009
Decision Date 06/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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