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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
Classification Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
Product Code: FJS
Device Class: 2
Regulation Number: 876.5630
Medical Specialty: Gastroenterology
Registered Establishment Name: Sterigenics EO Canada, Inc.
Registered Establishment Number: 9611665
Premarket Submission Number: K993149
Owner/Operator: Sotera Health LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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