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Negative Pressure Wound Therapy Non-Powered Suction Apparatus

FDA product code OKO · 13 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4683
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2011-07-21 – 2026-09-18

A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.

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