FDA 510(k) Application Details - K082993

Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin

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510(K) Number K082993
Device Name Tissue Adhesive For The Topical Approximation Of Skin
Applicant ADHEZION BIOMEDICAL
506 PINE MOUNTAIN RD
HUDSON, NC 28638 US
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Contact RICHARD G JONES
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Regulation Number 878.4010

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Classification Product Code MPN
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Date Received 10/07/2008
Decision Date 12/19/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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