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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 K052383
Device Name INNOCURE IMRT FILTER (COMPENSATORS)
Applicant
Innocure, LLC
201 E. Southern Ave.
Suites 201 & 202
Tempe,  AZ  85282
Applicant Contact DONALD W COLLINS
Correspondent
Innocure, LLC
201 E. Southern Ave.
Suites 201 & 202
Tempe,  AZ  85282
Correspondent Contact DONALD W COLLINS
Regulation Number892.5710
Classification Product Code
IXI  
Date Received08/30/2005
Decision Date 03/29/2006
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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