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510(k) K113330

CABLECAP by Sensormed — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2012
Date Received
November 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K090070 — INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (April 22, 2009)