SOUTH EAST INSTRUMENTS LLC

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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

Scaler, Ultrasonic (ELC) (4)

Premarket Exempt

Yes

Clear

Autoscaler® - 00859191006007 Catalog Number :

Device Description : 25K Ultrasonic Scaler 120 VAC

Device Class : 2

Duns Number: 080231739

Premarket Exempt : Yes

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Autoscaler® - 00859191006014 Catalog Number :

Device Description : 30K Ultrasonic Scaler 120 VAC

Device Class : 2

Duns Number: 080231739

Premarket Exempt : Yes

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Autoscaler® - 00859191006021 Catalog Number :

Device Description : 25K Build In Ultrasonic Scaler 120 VAC

Device Class : 2

Duns Number: 080231739

Premarket Exempt : Yes

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Autoscaler® - 00859191006038 Catalog Number :

Device Description : 30K Build In Ultrasonic Scaler 120 VAC

Device Class : 2

Duns Number: 080231739

Premarket Exempt : Yes

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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