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U.S. Department of Health and Human Services

Product Classification
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Device sensor,electro-optical(for cervical cancer)
Definition An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells.
Review Panel Obstetrics/Gynecology
Product CodeMWM
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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