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Title 21 Part 886 → Subpart E → §886.4270

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart E → §886.4270

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart E → §886.4270

e-CFR data is current as of June 18, 2019

Title 21Chapter ISubchapter HPart 886Subpart E → §886.4270


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices


§886.4270   Intraocular gas.

(a) Identification. An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure on a detached retina.

(b) Classification. Class III.

(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 §886.3.