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U.S. Department of Health and Human Services

Product Classification

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Device kit, catheter, foley (excludes hiv testing)
Regulation Description Urological catheter and accessories.
Definition Foley Catheter Kit (Excludes HIV Testing)
Physical State Foley Catheter Kit (Excludes HIV Testing)
Technical Method Foley Catheter Kit (Excludes HIV Testing)
Target Area Foley Catheter Kit (Excludes HIV Testing)
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNWR
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
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
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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