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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CONTEC21 Oxygen Concentrator; OC3D Oxygen Concentrator; OC3D(Stratus 10) Oxygen Concentrator
Classification Name: GENERATOR, OXYGEN, PORTABLE
Product Code: CAW
Device Class: 2
Regulation Number: 868.5440
Medical Specialty: Anesthesiology
Registered Establishment Name: CONTEC MEDICAL SYSTEMS CO., LTD
Registered Establishment Number: 3006979678
Premarket Submission Number: K180837
Owner/Operator: CONTEC MEDICAL SYSTEMS CO., LTD
Owner/Operator Number: 10025156
Establishment Operations: Manufacturer
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