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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K014022
Device Name MRI LINE MARKER
Applicant
I.Z.I. Corp.
7020 Tudsbury Rd.
Baltimore,  MD  21244
Applicant Contact HELEN ZINREICH
Correspondent
I.Z.I. Corp.
7020 Tudsbury Rd.
Baltimore,  MD  21244
Correspondent Contact HELEN ZINREICH
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/06/2001
Decision Date 03/04/2002
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
Recalls CDRH Recalls
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