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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, Fluoroscopic, Image-Intensified
510(k) Number K962606
Device Name TOPOGRAPHIC IMAGING MARKER
Applicant
I.Z.I. Medical Products Corp.
10 Stream Ct.
Owings Mills,  MD  21117
Applicant Contact S. JAMES ZINREICH
Correspondent
I.Z.I. Medical Products Corp.
10 Stream Ct.
Owings Mills,  MD  21117
Correspondent Contact S. JAMES ZINREICH
Regulation Number892.1650
Classification Product Code
JAA  
Date Received07/02/1996
Decision Date 08/07/1996
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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