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FDA 510(k) Application Details - K972617
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K972617
Device Name
Accelerator, Linear, Medical
Applicant
HELAX AB
KLOSTERG. 12
UPPSALA S-75147 SE
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Contact
JAN TORNQVIST
Other 510(k) Applications for this Contact
Regulation Number
892.5050
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Classification Product Code
IYE
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More FDA Info for this Product Code
Date Received
07/09/1997
Decision Date
10/01/1997
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
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