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Negative Pressure Wound Therapy Powered Suction Pump

FDA product code OMP · 185 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4780
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1997-05-22 – 2026-09-11

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. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

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