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U.S. Department of Health and Human Services

Product Classification

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Device suture, surgical, absorbable, polydioxanone
Regulation Description Absorbable polydioxanone surgical suture.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeNEW
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4840
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Documents
Third Party Review Not Third Party Eligible
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