FDA 510(k) Application Details - K081821

Device Classification Name Container, Sharps

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510(K) Number K081821
Device Name Container, Sharps
Applicant GLOBAL PATHOGEN SOLUTIONS INC.
9515 N.E. 312TH AVE.
CAMAS, WA 98607 US
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Contact CARSON LINKER
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 06/27/2008
Decision Date 09/02/2008
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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