OBALON THERAPEUTICS, INC.

Address:5421 Avenida Encinas,Carlsbad,CA,92008,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Implant, Intragastric For Morbid Obesity (LTI) (10)

Premarket Exempt

No Yes

Clear

OBALON® Placebo Capsule - 00859810006005 Catalog Number :

Device Description : OBALON® Placebo Capsule - component for use with the OBALON® Balloon System

Device Class :

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

OBALON® EzFill™ Can - 00859810006012 Catalog Number :

Device Description : OBALON® EzFill™ Can - component to inflate the OBALON® Balloon System

Device Class : 3

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

OBALON® EzFill™ Dispenser - 00859810006029 Catalog Number :

Device Description : OBALON® EzFill™ Dispenser - component to inflate the OBALON® Balloon System

Device Class : 3

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

OBALON® Balloon Kit - 00859810006036 Catalog Number :

Device Description : Intragastric Balloon

Device Class : 3

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

OBALON® Accessory Kit - 00859810006043 Catalog Number :

Device Description : OBALON® Accessory Kit - component for use with the OBALON® Balloon System

Device Class : 3

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

OBALON® Balloon System - 00859810006050 Catalog Number :

Device Description : OBALON® Balloon System - contains one Obalon Balloon Kit and one Obalon Accessory Kit

Device Class : 3

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

OBALON® Balloon Kit HPMC - 00859810006067 Catalog Number :

Device Description : Intragastric Balloon

Device Class : 3

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

OBALON® Balloon System HPMC - 00859810006074 Catalog Number :

Device Description : OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalo OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalon Accessory Kit

Device Class :

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

OBALON® Placebo Capsule HPMC - 00859810006081 Catalog Number :

Device Description : OBALON® Placebo Capsule HPMC - component for use with the OBALON® Balloon System

Device Class :

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

OBALON Touch™ - 00859810006104 Catalog Number :

Device Description : OBALON Touch™ Dispenser - component to inflate the OBALON® Balloon

Device Class : 3

Duns Number: 022894714

Premarket Exempt : No

Product Code : LTI

Prescription Use : Yes

Device Count : 1

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