{"data":{"id":"us/21-cfr-878.3925","jurisdiction":"us","citation":"21 CFR 878.3925","heading":"Plastic surgery kit and accessories.","body":"(a) Identification. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.","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 D—Prosthetic 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":"59dc8d621a07910f775e39b8e18dca6f8fe2c2a993c228472241f9548df536c9","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.3910","next":"us/21-cfr-878.4010"},"notice":"GroundRules: Original legal text. Not legal advice."}