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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 K090378
Device Name CHROMOPHARE E 668
Applicant
Berchtold GmbH & Co. KG
1950 Hanahan Rd.
Charleston,  SC  29406
Applicant Contact HEATH HINES
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number878.4580
Classification Product Code
FSY  
Date Received02/17/2009
Decision Date 02/23/2009
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
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