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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 K102811
Device Name AOS ORION IR-192 SOURCE CABLE
Applicant
Alpha-Omega Services, Inc.
9156 Rose St.
Bellflower,  CA  90706
Applicant Contact BOB A ROBNETT
Correspondent
Alpha-Omega Services, Inc.
9156 Rose St.
Bellflower,  CA  90706
Correspondent Contact BOB A ROBNETT
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/28/2010
Decision Date 06/02/2011
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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