21 C.F.R. § 886.4360 Ocular surgery irrigation device.
Title 21 - Food and Drugs
(a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field. (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 the limitations in §886.9. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices
§ 886.4360 Ocular surgery irrigation device.
