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U.S. Department of Health and Human Services

Product Classification
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Device expander, breast, external
Regulation Description Therapeutic massager.
Regulation Medical Specialty Physical Medicine
Review Panel General & Plastic Surgery
Product CodeMWZ
Premarket Review Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type Enforcement Discretion
Regulation Number 890.5660
Device Class 1
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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