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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K960973
Device Name MOVABLE ADD-ON COUCH FOR OUTLOOK
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact ELAINE K KEELER, PH.D.
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact ELAINE K KEELER, PH.D.
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
JAA  
Date Received03/11/1996
Decision Date 05/29/1996
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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