{"data":{"id":"us/21-cfr-878.4490","jurisdiction":"us","citation":"21 CFR 878.4490","heading":"Absorbable hemostatic agent and dressing.","body":"(a) Identification. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.\n(b) Classification. Class III.\n(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart E—Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"f20176d3383d7b9d02c18d4c917d6d7f9a2ec1de0b67da107c480db3c6e84803","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4470","next":"us/21-cfr-878.4493"},"notice":"GroundRules: Original legal text. Not legal advice."}