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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 K063333
Device Name M3
Applicant
Mavig GmbH
Stahlgruberring 5
Munchen,  DE 81829
Applicant Contact CHRISTIAN STOIAN
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFFERY D RONGERO
Regulation Number878.4580
Classification Product Code
FSY  
Date Received11/06/2006
Decision Date 11/21/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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