21 C.F.R. § 880.5640 Lamb feeding nipple.
Title 21 - Food and Drugs
(a) Identification. A lamb feeding nipple is a device intended for use as a feeding nipple for infants with oral or facial abnormalities. (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 §880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files. [45 FR 69682–69737, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices
§ 880.5640 Lamb feeding nipple.
