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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Biatain Silicone AG
Classification Name: DRESSING, WOUND, DRUG
Product Code: FRO
Device Class: Unclassified
Registered Establishment Name: COLOPLAST A/S
Registered Establishment Number: 9610694
Premarket Submission Number: K191536
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Specification Developer
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