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FDA 510(k) Application Details - K961601
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
More FDA Info for this Device
510(K) Number
K961601
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
1470 OUTLOOK AVE.
P.O. BOX 99
BRONX, NY 10465 US
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Contact
FELIX W MICK
Other 510(k) Applications for this Contact
Regulation Number
892.5700
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Classification Product Code
JAQ
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More FDA Info for this Product Code
Date Received
04/25/1996
Decision Date
12/23/1996
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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