Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Softwar ...



Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.
Components:
Recall Date:    May 23, 2019
Mfg:
Obalon Therapeutics Inc
Mfg Country:
United States
Recall ID:    85050
Product ID:    179972
Enforcement Date:    May 6, 2020
Last Published:    Nov 9, 2020

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Emert Number:    Z-1805-2020
Emert Status:    Announced