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Title 21 Part 880 → Subpart F → §880.5075

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F → §880.5075

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F → §880.5075

e-CFR data is current as of July 12, 2019

Title 21Chapter ISubchapter HPart 880Subpart F → §880.5075


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices


§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.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]