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FDA 510(k) Application Details - DEN070002
Device Classification Name
Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
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510(K) Number
DEN070002
Device Name
Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
Applicant
QUICK-MED TECHNOLOGIES, INC.
3427 SW 42ND WAY
GAINESVILLE, FL 32608 US
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ROY CARR
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Regulation Number
878.4015
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Classification Product Code
NYS
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Date Received
05/10/2007
Decision Date
02/25/2009
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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