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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 K020683
Device Name ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
Applicant
Ati Medical, Inc.
10954-A Via Frontera
San Diego,  CA  92127
Applicant Contact MICHAEL WIENHOLT
Correspondent
Ati Medical, Inc.
10954-A Via Frontera
San Diego,  CA  92127
Correspondent Contact MICHAEL WIENHOLT
Regulation Number892.5730
Classification Product Code
KXK  
Date Received03/04/2002
Decision Date 12/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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