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U.S. Department of Health and Human Services

Product Classification

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Device pad, alcohol, device disinfectant
Review Panel General Hospital
Product CodeLKB
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Unclassified Reason Pre-Amendment
Submission Type Enforcement Discretion
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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