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FDA 510(k) Application Details - K964607
Device Classification Name
Device, Beam Limiting, Teletherapy, Radionuclide
More FDA Info for this Device
510(K) Number
K964607
Device Name
Device, Beam Limiting, Teletherapy, Radionuclide
Applicant
THERATRONICS, INC.
413 MARCH ROAD
P.O. BOX 13140
KANATA ONTARIO K2K 2B7 CA
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Contact
E.S. MARTELL
Other 510(k) Applications for this Contact
Regulation Number
892.5750
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Classification Product Code
IWD
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More FDA Info for this Product Code
Date Received
11/18/1996
Decision Date
05/28/1997
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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