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FDA 510(k) Application Details - K100801
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K100801
Device Name
Accelerator, Linear, Medical
Applicant
PROWESS, INC.
1844 CLAYTON ROAD
CONCORD, CA 94520 US
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Contact
RACHEL SCARANO
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/2010
Decision Date
06/18/2010
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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