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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 K964752
Device Name KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER
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  
Date Received11/27/1996
Decision Date 02/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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