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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 K071964
Device Name MIM 4.1 (SEASTAR)
Applicant
MIMVISTA CORP.
25200 CHAGRIN BLVD. SUITE 200
CLEVELAND,  OH  44122
Applicant Contact PETER SIMMELINK
Correspondent
MIMVISTA CORP.
25200 CHAGRIN BLVD. SUITE 200
CLEVELAND,  OH  44122
Correspondent Contact PETER SIMMELINK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/16/2007
Decision Date 09/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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