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FDA 510(k) Application Details - K081821
Device Classification Name
Container, Sharps
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
MMK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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