FDA 510(k) Application Details - K990734

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K990734
Device Name Accelerator, Linear, Medical
Applicant SCANDITRONIX MEDICAL AB
STALGATAN 14
UPPSALA S-754 50 SE
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Contact EVA LARSTEN
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 03/05/1999
Decision Date 05/28/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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