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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 K130933
Device Name SOLUTIS
Applicant
Quantel Medical
5 Timber Lane
North Reading,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
Quantel Medical
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received04/04/2013
Decision Date 08/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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