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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Non-Powered Air-Purifying Particle Respirator.KN95
Classification Name: N95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MEDICAL EMERGENCIES
Product Code: ORW
Device Class: 2
Regulation Number: 880.6260
Medical Specialty: General Hospital
Registered Establishment Name: GUANGZHOU LINGYANG MEDICAL EQUIPMENTCO., LTD.
Registered Establishment Number: 3017103494
Owner/Operator: Guangzhou LINGYANG MEDICAL EQUIPMENTCo., Ltd.
Owner/Operator Number: 10069486
Establishment Operations: Foreign Exporter; Manufacturer
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