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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K080601
Device Name ERGO++ VERSION 1.7
Applicant
3D LINE MEDICAL SYSTEMS S.R.L.
4775 PEACHTREE INDUSTRIAL BLVD
BLDG 300, SUITE 300
NORCROSS,  GA  30092
Applicant Contact THOMAS VALENTINE
Correspondent
3D LINE MEDICAL SYSTEMS S.R.L.
4775 PEACHTREE INDUSTRIAL BLVD
BLDG 300, SUITE 300
NORCROSS,  GA  30092
Correspondent Contact THOMAS VALENTINE
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/03/2008
Decision Date 06/06/2008
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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