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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 21096A Foley Catheter Temperature Probe 16FR; 21097A Foley Catheter Temperature Probe 18FR; M2255A Foley Catheter Temperature Probe 14FR
Classification Name: CATHETER, RETENTION TYPE, BALLOON
Product Code: EZL
Device Class: 2
Regulation Number: 876.5130
Medical Specialty: Gastroenterology
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K921561
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Repackager/Relabeler
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