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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 K043236
Device Name FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
Applicant
Quantel Medical
342 Sunset Bay Rd.
Hot Springs,  AR  71913
Applicant Contact ROGER W BARNES
Correspondent
Quantel Medical
342 Sunset Bay Rd.
Hot Springs,  AR  71913
Correspondent Contact ROGER W BARNES
Regulation Number886.4390
Classification Product Code
HQF  
Date Received11/22/2004
Decision Date 02/07/2005
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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