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510(k) K151829

Atlas SPEEDER Header/Neck by Quality Electrodynamics, LLC — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2015
Date Received
July 6, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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