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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K992335
Device Name BEACON-P, MODEL 211059
Applicant
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd.
Cleveland,  OH  44143
Applicant Contact RONALD J MARTONE
Correspondent
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd.
Cleveland,  OH  44143
Correspondent Contact RONALD J MARTONE
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/13/1999
Decision Date 10/07/1999
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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