NYS · Class II · 21 CFR 878.4015

FDA Product Code NYS: Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac)

A Wound Dressing With Poly (diallyl Dimethyl Ammonium Chloride) (pdadmac) Additive Is A Device That Is A Sterile Barrier Wound Dressing Intended For Use As A Primary Dressing For Exuding Wounds, First And Second Degree Burns, And Surgical Wounds, To Secure And Prevent Movement Of A Primary Dressing, And As A Wound Packing. The Device Consists Of A Textile Substrate And Permanently Bound Pdadmac. The Device Acts As A Physical Barrier To Outside Contaminants And Does Not Act On The Surface Or Interior Of The Wound Nor Does It Contain Antimicrobial Agents That Act On The Body.

1
Total
0
Cleared
657d
Avg days
2009
Since

FDA 510(k) Cleared Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac) Devices (Product Code NYS)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code NYS - Regulatory Context