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510(k) K130513

VOLISTA 400; VOLISTA 600 by Maquet S.A.S. — Product Code FTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2013
Date Received
February 27, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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