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Drape, Surgical, Antimicrobial

FDA product code KKX · 442 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4370
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1976-08-11 – 2023-10-25

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

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