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Balloon, Nasal Airway

FDA product code QGK · 1 cleared devices

Class 1 Ear, Nose, Throat
Regulation
21 CFR 874.4420
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-04-19 – 2019-04-19

The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.

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