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U.S. Department of Health and Human Services

Product Classification

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Device kit, catheter, urinary (exludes hiv testing)
Definition Urinary Catheterization Kit (Excludes HIV Testing)
Physical State Urinary Catheterization Kit (Excludes HIV Testing)
Technical Method Urinary Catheterization Kit (Excludes HIV Testing)
Target Area Urinary Catheterization Kit (Excludes HIV Testing)
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNWO
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.5130
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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