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U.S. Department of Health and Human Services

Product Classification

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Device sheet, recording, breast examination
Regulation Description Breast lesion documentation system.
Definition This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeNHM
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.2990
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible