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FDA 510(k) Application Details - K083129
Device Classification Name
Container, Sharps
More FDA Info for this Device
510(K) Number
K083129
Device Name
Container, Sharps
Applicant
SHARPS COMPLIANCE, INC.
9220 KIRBY DR., SUITE 500
HOUSTON, TX 77054 US
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Contact
AL ALADWANI
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
10/22/2008
Decision Date
12/15/2008
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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