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FDA 510(k) Application Details - DEN080011
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OKO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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