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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: SpeediCath Soft
Classification Name: CATHETER, URETHRAL
Product Code: GBM
Device Class: 2
Regulation Number: 876.5130
Medical Specialty: Gastroenterology
Registered Establishment Name: Coloplast Costa Rica SA
Registered Establishment Number: 3015131144
Premarket Submission Number: K200142
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Manufacturer
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