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510(k) K111342

LIGHT GUIDE CABLE by Schott North America — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2011
Date Received
May 13, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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  • K922462 — NEXTEC FIBEROPTIC CABLES (September 21, 1992)