FDA 510(k) Application Details - K063666

Device Classification Name Container, Sharps

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510(K) Number K063666
Device Name Container, Sharps
Applicant BIODEX MEDICAL SYSTEMS, INC.
20 RAMSAY RD.
SHIRLEY, NY 11967 US
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Contact CLYDE SCHLEIN
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 12/11/2006
Decision Date 01/25/2007
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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