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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Classification Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
Product Code: FMI
Device Class: 2
Regulation Number: 880.5570
Medical Specialty: General Hospital
Registered Establishment Name: 15445361 CANADA INC.
Registered Establishment Number: 3043051314
Premarket Submission Number: K982541
Owner/Operator: 15445361 Canada Inc.
Owner/Operator Number: 10094832
Establishment Operations: Foreign Exporter
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