FDA 510(k) Application Details - K091690

Device Classification Name Container, Sharps

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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
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Regulation Number 880.5570

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Classification Product Code MMK
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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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