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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 K883621
Device Name INSTRUMENTARIUM ULF MR IMAGING SYSTEM
Applicant
INSTRUMENTARIUM CORP.
hyman, phelps & mcnamara, p.c.
1120 g street, n.w.
washington,  DC  20005
Applicant Contact robert dormer
Correspondent
INSTRUMENTARIUM CORP.
hyman, phelps & mcnamara, p.c.
1120 g street, n.w.
washington,  DC  20005
Correspodent Contact robert dormer
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/25/1988
Decision Date 11/10/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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