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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K022074
Device Name SPHERZ
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 Number882.4560
Classification Product Code
HAW  
Date Received06/26/2002
Decision Date 08/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
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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