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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Sure Cath Set
Classification Name: CATHETER, STRAIGHT
Product Code: EZD
Device Class: 2
Regulation Number: 876.5130
Medical Specialty: Gastroenterology
Registered Establishment Name: Coloplast Hungary, KFT
Registered Establishment Number: 3008262278
Premarket Submission Number: K973070
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Repackager/Relabeler
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