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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: DemeMASK Surgical Mask
Classification Name: MASK, SURGICAL
Product Code: FXX
Device Class: 2
Regulation Number: 878.4040
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: DEMETECH CORP.
Registered Establishment Number: 1064584
Premarket Submission Number: K201479
Owner/Operator: DEMETECH CORP.
Owner/Operator Number: 9041973
Establishment Operations: Manufacturer