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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Contact 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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