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FDA 510(k) Application Details - K152340
Device Classification Name
Container, Sharps
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510(K) Number
K152340
Device Name
Container, Sharps
Applicant
North American Rescue, LLC
35 Tedwall Court
Greer, SC 29650 US
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Contact
William Slevin
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
MMK
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More FDA Info for this Product Code
Date Received
08/19/2015
Decision Date
05/31/2016
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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