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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 K063392
Device Name IMCO-STAT
Applicant
IMCO TECHNOLOGIES
N27 W23957 PAUL RD.,SUITE 101
pewaukee,  WI  53072
Applicant Contact mark l schwartz
Correspondent
IMCO TECHNOLOGIES
N27 W23957 PAUL RD.,SUITE 101
pewaukee,  WI  53072
Correspondent Contact mark l schwartz
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/09/2006
Decision Date 12/12/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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