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510(k) K173299

DRAGON X SPSL4HC, DRAGON X SPSL8HC by Sedecal., Sa. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2018
Date Received
October 17, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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