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Mesh, Surgical, Deployment Balloon

FDA product code OQL · 1 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.3300
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2010-03-15 – 2010-03-15

The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.

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