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510(k) K151426

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ by Scandidos AB — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2016
Date Received
May 28, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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