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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K233348
Device Name 16 Breast Coil
Applicant
Philips Medical System Nederlands B.V.
Veenpluis 6
Best,  NL 5684 PC
Applicant Contact Shruti Sancheti
Correspondent
Philips Medical System Nederlands B.V.
Veenpluis 6
Best,  NL 5684 PC
Correspondent Contact Shruti Sancheti
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/29/2023
Decision Date 10/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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