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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K990298
Device Name TOPOGRAPHIC IMAGING MARKER
Applicant
I.Z.I. Medical Products Corp.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
I.Z.I. Medical Products Corp.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
JAA  
Date Received02/01/1999
Decision Date 03/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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