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FDA 510(k) Application Details - K200221
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
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510(K) Number
K200221
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Avenue
Mount Vernon, NY 10550 US
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Contact
James Hurlman
Other 510(k) Applications for this Contact
Regulation Number
892.5700
More FDA Info for this Regulation Number
Classification Product Code
JAQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/29/2020
Decision Date
02/28/2020
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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