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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, ceiling mounted
510(k) Number K011693
Device Name TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
Applicant
TRUMPF MEDICAL SYSTEMS, INC.
415 JESSEN LN.
WANDO,  SC  29492
Applicant Contact WILLIAM APPERSON
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact KENT DONOHUE
Regulation Number878.4580
Classification Product Code
FSY  
Date Received05/31/2001
Decision Date 06/13/2001
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
Recalls CDRH Recalls
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