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FDA 510(k) Application Details - K111979
Device Classification Name
Source, Brachytherapy, Radionuclide
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510(K) Number
K111979
Device Name
Source, Brachytherapy, Radionuclide
Applicant
BIOCOMPATIBLES INC.
115 Hurley Rd Bldg 3F
OXFORD, CT 06478 US
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Contact
WAYNE RICHARDSON
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Regulation Number
892.5730
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Classification Product Code
KXK
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More FDA Info for this Product Code
Date Received
07/12/2011
Decision Date
10/18/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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