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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K062826
Device Name AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
Applicant
Alpha-Omega Services, Inc.
9156 Rose St.
Bellflower,  CA  90706
Applicant Contact BOB A BOBNETT
Correspondent
Alpha-Omega Services, Inc.
9156 Rose St.
Bellflower,  CA  90706
Correspondent Contact BOB A BOBNETT
Regulation Number892.5700
Classification Product Code
JAQ  
Subsequent Product Code
KXK  
Date Received09/20/2006
Decision Date 05/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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