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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Biatain Ag Adhesive; Biatain Ag Non-Adhesive
Classification Name: DRESSING, WOUND, DRUG
Product Code: FRO
Device Class: Unclassified
Registered Establishment Name: COLOPLAST HUNGARY KFT
Registered Establishment Number: 3006606901
Premarket Submission Number: K100218
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Manufacturer
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