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510(k) K133554

SURGICAL LIGHT HANDLE COVER by Microtek Medical, Inc. an Ecolab Company — Product Code FTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2014
Date Received
November 19, 2013
Clearance Type
Special
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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