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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K964968
Device Name MR EXTENSION SET (001)
Applicant
University of Michigan
1500 E. Medical Center Dr.
Ann Arbor,  MI  48109
Applicant Contact MARTIN R PRINCE, MD, PH.D.
Correspondent
University of Michigan
1500 E. Medical Center Dr.
Ann Arbor,  MI  48109
Correspondent Contact MARTIN R PRINCE, MD, PH.D.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/12/1996
Decision Date 02/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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