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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
Predetermined Change
Control Plan Authorized		 No
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