FDA 510(k) Application Details - DEN080011

Device Classification Name

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510(K) Number DEN080011
Device Name SNAP WOUND CARE DEVICE
Applicant SPIRACUR, INC.
1835 MARKET STREET
SUITE 2820
PHILADELPHIA, PA 19103 US
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Contact JANICE M HOGAN
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Regulation Number

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Classification Product Code OKO
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Date Received 11/03/2008
Decision Date 08/07/2009
Decision DENG -
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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