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510(k) K142386

Operating Room Light Handle Adapter by Litex Manufacturing, Inc. — Product Code FTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2014
Date Received
August 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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