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U.S. Department of Health and Human Services

Product Classification

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Device suture, nonabsorbable, steel, monofilament and multifilament, sterile
Regulation Description Stainless steel suture.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeGAQ
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4495
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA
Third Party Review Not Third Party Eligible
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