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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BT-350
Classification Name: TRANSDUCER, ULTRASONIC, OBSTETRIC
Product Code: HGL
Device Class: 2
Regulation Number: 884.2960
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: Bistos co., ltd.
Registered Establishment Number: 3006179052
Owner/Operator: Bistos co., ltd.
Owner/Operator Number: 10023402
Establishment Operations: Manufacturer
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