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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
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 69682-69737, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]
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