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FDA 510(k) Application Details - K091690
Device Classification Name
Container, Sharps
More FDA Info for this Device
510(K) Number
K091690
Device Name
Container, Sharps
Applicant
HEATHROW SCIENTIFIC, LLC
620 LAKEVIEW PKWY
VERNON HILLS, IL 60061 US
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Contact
PETE HADJIS
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
06/10/2009
Decision Date
07/28/2009
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
Y
Expedited Review
FDA Source Information for K091690
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