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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Biotronik ¿ Atrial Capture Control and Ventricular Pacing Supression
Classification Name: PULSE GENERATOR, EXTERNAL PACEMAKER, DUAL-CHAMBER
Product Code: OVJ
Device Class: 3
Regulation Number: 870.3600
Medical Specialty: Cardiovascular
Registered Establishment Name: MAQUILAS TETA KAWI S.A. DE C.V., DEPARTMENTO: PREC
Registered Establishment Number: 3003615065
Owner/Operator: TE Connectivity Ltd.
Owner/Operator Number: 9060212
Establishment Operations: Contract Manufacturer
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