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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K041702
Device Name EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
Applicant
Ibt SA
6000 Live Oak Pkwy., Suite 107
Norcross,  GA  30093
Applicant Contact RUTH FEICHT
Correspondent
Ibt SA
6000 Live Oak Pkwy., Suite 107
Norcross,  GA  30093
Correspondent Contact RUTH FEICHT
Regulation Number892.5730
Classification Product Code
KXK  
Date Received06/22/2004
Decision Date 07/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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