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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: In-Ka Percutaneous Balloon Catheter and Amplatz Sheath
Classification Name: CATHETER, NEPHROSTOMY
Product Code: LJE
Device Class: Unclassified
Registered Establishment Name: Centre de distribution Coloplast Le Plessis Pate
Registered Establishment Number: 3012649202
Premarket Submission Number: K201165
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Foreign Exporter
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