FDA 510(k) Application Details - K050888

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K050888
Device Name Accelerator, Linear, Medical
Applicant DIACOR, INC.
3191 SOUTH 3300 EAST,
SUITE 100-A
SALT LAKE CITY, UT 84109 US
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Contact GLENN N WATERMAN
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 04/07/2005
Decision Date 05/23/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K050888


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