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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3M Tie-On Surgical Mask; Mask, surgical
Classification Name: MASK, SURGICAL
Product Code: FXX
Device Class: 2
Regulation Number: 878.4040
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: 3M EDUMEX, S.A DE C.V
Registered Establishment Number: 9680284
Premarket Submission Number: K940707
Owner/Operator: 3M COMPANY
Owner/Operator Number: 2110898
Establishment Operations: Contract Manufacturer
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