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U.S. Department of Health and Human Services

Product Classification

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Device mask, surgical
Regulation Description Surgical apparel.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeFXX
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery (DHT4B)
Submission Type 510(k)
Regulation Number 878.4040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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