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FDA 510(k) Application Details - K110900
Device Classification Name
Shield, Protective, Personnel
More FDA Info for this Device
510(K) Number
K110900
Device Name
Shield, Protective, Personnel
Applicant
BLOXR CORPORATION
2116 LAKE CITY
SALT LAKE CITY, UT 84109 US
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Contact
RAI CHOWDHARY
Other 510(k) Applications for this Contact
Regulation Number
892.6500
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Classification Product Code
KPY
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More FDA Info for this Product Code
Date Received
03/31/2011
Decision Date
06/24/2011
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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