FDA 510(k) Application Details - K063722

Device Classification Name Container, Sharps

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510(K) Number K063722
Device Name Container, Sharps
Applicant TECHEN SAFETY, INC.
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
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Contact SID MATHUR
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 12/15/2006
Decision Date 03/05/2007
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 Y
Expedited Review



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