FDA 510(k) Application Details - K990383

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K990383
Device Name Accelerator, Linear, Medical
Applicant PRECITRON A.B.
ULTUNAALLEN 2
UPPSALA S-756 51 SE
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Contact KJELL WESTERLUND
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 02/08/1999
Decision Date 05/05/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K990383


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