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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, Film Marking, Radiographic
510(k) Number K930752
Device Name CT/MRI TOPOGRAPHIC MARKER
Applicant
I.Z.I. Corp.
10 Stream Ct.
Owings Mills,  MD  21117
Applicant Contact JAMES ZINREICH
Correspondent
I.Z.I. Corp.
10 Stream Ct.
Owings Mills,  MD  21117
Correspondent Contact JAMES ZINREICH
Regulation Number892.1640
Classification Product Code
JAC  
Date Received02/12/1993
Decision Date 11/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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