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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 K020071
Device Name VIRIDIS DERMA LASER
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 Number878.4810
Classification Product Code
GEX  
Date Received01/09/2002
Decision Date 04/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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