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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Radionuclide
510(k) Number K102533
Device Name ROTATING GAMMA SYSTEM INFINI (INFINI)
Applicant
Masep Medical Science & Tech.Development (Shenzhen
55 Northren Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Masep Medical Science & Tech.Development (Shenzhen
55 Northren Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number892.5750
Classification Product Code
IWB  
Subsequent Product Code
MUJ  
Date Received09/03/2010
Decision Date 03/22/2011
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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