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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K060187
Device Name TOPSLANE DMLC
Applicant
Topslane International, LLC
15375 Roosevelt Blvd.
Suite # 300
Clearwater,  FL  33760
Applicant Contact JIM MARSH
Correspondent
Topslane International, LLC
15375 Roosevelt Blvd.
Suite # 300
Clearwater,  FL  33760
Correspondent Contact JIM MARSH
Regulation Number892.5710
Classification Product Code
IXI  
Subsequent Product Code
IYE  
Date Received01/24/2006
Decision Date 07/27/2006
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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