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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: HAC-300 Head Array Coil
Classification Name: COIL, MAGNETIC RESONANCE, SPECIALTY
Product Code: MOS
Device Class: 2
Regulation Number: 892.1000
Medical Specialty: Radiology
Registered Establishment Name: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Registered Establishment Number: 3003768277
Premarket Submission Number: K001944
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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