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FDA 510(k) Application Details - K131708
Device Classification Name
Container, Sharps
More FDA Info for this Device
510(K) Number
K131708
Device Name
Container, Sharps
Applicant
BRADFORD WRIGHT COMPANIES, INC
4092 ORCHARD WAY
LAKE OSWEGO, OR 97035-1871 US
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Contact
MIKE DEMELLO
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
MMK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/11/2013
Decision Date
03/10/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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