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U.S. Department of Health and Human Services

Product Classification

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Device suture, recombinant technology
Regulation Description Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
Definition Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Physical State Polymer (solid)
Technical Method Produced through recombinant DNA technology
Target Area General soft tissues in the body.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeNWJ
Premarket Review Infection Control and Plastic Surgery Devices (DHT4B)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4494
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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