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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
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