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Wound Drain Catheter System

FDA product code OTK · 6 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4780
Review panel
SU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2010-12-03 – 2021-03-02

For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.

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