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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 K024183
Device Name ALTON PT STEPPER
Applicant
Alton Design, LLC
2655 N. Ocean Dr.
Suite 403
Singer Island,  FL  33404
Applicant Contact GREG WIITA
Correspondent
Alton Design, LLC
2655 N. Ocean Dr.
Suite 403
Singer Island,  FL  33404
Correspondent Contact GREG WIITA
Regulation Number892.5730
Classification Product Code
KXK  
Subsequent Product Code
ITX  
Date Received12/19/2002
Decision Date 03/17/2003
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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