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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 K080120
Device Name HFO SHOULDER COIL
Applicant
Philips Medical Systems MR Finland
595 Miner Rd.
Cleveland,  OH  44143
Applicant Contact CATHERINE CONNELL
Correspondent
Philips Medical Systems MR Finland
595 Miner Rd.
Cleveland,  OH  44143
Correspondent Contact CATHERINE CONNELL
Regulation Number892.1000
Classification Product Code
MOS  
Date Received01/17/2008
Decision Date 03/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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