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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K922287
Device Name E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS
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 Number892.5840
Classification Product Code
KPQ  
Date Received05/15/1992
Decision Date 10/16/1992
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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