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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Fiberoptic, Surgical Field
510(k) Number K111342
Device Name LIGHT GUIDE CABLE
Applicant
Schott North America
40 Plain St.
North Attleboro,  MA  02760
Applicant Contact JEFFREY ROBERTS
Correspondent
Schott North America
40 Plain St.
North Attleboro,  MA  02760
Correspondent Contact JEFFREY ROBERTS
Regulation Number878.4580
Classification Product Code
HBI  
Date Received05/13/2011
Decision Date 11/25/2011
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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