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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 Plastic and Reconstructive Surgery Devices (DHT4B)
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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