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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 K050317
Device Name BURANE XL
Applicant
WAVELIGHT LASER TECHNOLOGIE AG
AM WOLFSMANTEL 5
ERLANGEN,  DE 91058
Applicant Contact ALEXANDER POPP
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact WILLIAM J SAMMONS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/09/2005
Decision Date 02/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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