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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Band-Aid; Biatain Adhesive; Biatain Non-Adhesive; Biatain Non-Adhesive Foam Dressing; Biatain Silicone; Biatain Silicone Fit; Biatain Silicone Lite; Biatain Silicone Non-Border; Biatain Soft-Hold; Biatain Super; Brava Protective Sheets; Comfeel Plus Contour; Comfeel Plus Transparent; Neutrogena Acne Blemish Patch; Neutrogena Dots Sensitive
Classification Name: DRESSING, WOUND, OCCLUSIVE
Product Code: NAD
Device Class: 1
Regulation Number: 878.4020
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: COLOPLAST A/S
Registered Establishment Number: 9610694
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Specification Developer
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