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Title 21 Part 878 → Subpart E → §878.4840

Title 21 → Chapter I → Subchapter H → Part 878 → Subpart E → §878.4840

Electronic Code of Federal Regulations e-CFR

Title 21 Part 878 → Subpart E → §878.4840

e-CFR data is current as of January 24, 2020

Title 21Chapter ISubchapter HPart 878Subpart E → §878.4840


Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices


§878.4840   Absorbable polydioxanone surgical suture.

(a) Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

(b) Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See §878.1(e) for the availability of this guidance document.

[67 FR 77676, Dec. 19, 2002]