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U.S. Department of Health and Human Services

Product Classification

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Device ultrasound, skin permeation
Definition Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeNRJ
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4410
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
Recognized Consensus Standard
Third Party Review
Accredited Persons
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