Title 21: Food and Drugs
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/ PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
/ Subpart F - General Hospital and Personal Use Therapeutic Devices / § 880.5075 Elastic bandage.
§ 880.5075 Elastic bandage.
(a) Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.
(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. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation 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.