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U.S. Department of Health and Human Services

Product Classification

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Device tampon, menstrual, scented, deodorized
Regulation Description Scented or scented deodorized menstrual tampon.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeHIL
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.5460
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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