C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES › Subpart F—General Hospital and Personal Use Therapeutic Devices

21 C.F.R. § 880.5475

Jet lavage

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]
Notes of Decisions
Cited in 2 cases, 1997–1997 · leading case: Coyne Beahm, Inc. v. United States Food & Drug Admin., 966 F. Supp. 1374 (M.D.N.C. 1997).
Sort: Relevance Newest Treatment
Coyne Beahm, Inc. v. United States Food & Drug Admin., 966 F. Supp. 1374 (M.D.N.C. 1997). “4635 (ultraviolet lamps that deliver ultraviolet light which causes tanning); 21 C.”
Coyne Beahm, Inc. v. United States Food & Drug Admin., 958 F. Supp. 1060 (M.D.N.C. 1997). “4635 (ultraviolet lamps that deliver ultraviolet light which causes tanning); 21 C.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.