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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Amedic Tranducer, Ultrasonic, Obstetric; Needle Guide ; Transvaginal Ultrasound Biopsy
Classification Name: TRANSDUCER, ULTRASONIC, OBSTETRIC
Product Code: HGL
Device Class: 2
Regulation Number: 884.2960
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: ASCENDIA MEDTECH AB
Registered Establishment Number: 8032029
Owner/Operator: ASCENDIA MEDTECH AB
Owner/Operator Number: 8032029
Establishment Operations: Manufacturer
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