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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 K032599
Device Name MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM
Applicant
Medical Laser Technologies, LLC
516 Scott St.
Homewood,  AL  35209
Applicant Contact MARK ROHRER
Correspondent
Medical Laser Technologies, LLC
516 Scott St.
Homewood,  AL  35209
Correspondent Contact MARK ROHRER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/25/2003
Decision Date 10/29/2003
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
Predetermined Change
Control Plan Authorized		 No
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