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510(k) K233348

16 Breast Coil by Philips Medical System Nederlands B.V. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2023
Date Received
September 29, 2023
Clearance Type
Special
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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