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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K092041
Device Name STELLAR FIDUCIAL MARKER, MODEL GFMIA
Applicant
Stellar Medical, LLC
12738 Buckhorn Dr.
Hudson,  FL  34669
Applicant Contact BENJAMIN ROEDELL
Correspondent
Stellar Medical, LLC
12738 Buckhorn Dr.
Hudson,  FL  34669
Correspondent Contact BENJAMIN ROEDELL
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/07/2009
Decision Date 10/02/2009
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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