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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 K050862
Device Name 3TP WORKSPACE
Applicant
3TP LLC
245 MAIN ST., SUITE 620
WHITE PLAINS,  NY  10601
Applicant Contact MICHAEL KOCHIAN
Correspondent
3TP LLC
245 MAIN ST., SUITE 620
WHITE PLAINS,  NY  10601
Correspondent Contact MICHAEL KOCHIAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/05/2005
Decision Date 07/25/2005
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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