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FDA 510(k) Application Details - K964206
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K964206
Device Name
Accelerator, Linear, Medical
Applicant
NUCLETRON CORP.
7080 COLUMBIA GATEWAY DR.
COLUMBIA, MD 21046 US
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Contact
RANDOLPH HEMINGWAY
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
10/21/1996
Decision Date
06/20/1997
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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