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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Image Processing, Radiological
510(k) Number K963037
Device Name PATRIOT
Applicant
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact MORTEZA MINAEE
Correspondent
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact MORTEZA MINAEE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/05/1996
Decision Date 09/27/1996
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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