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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 890: PHYSICAL MEDICINE DEVICES
Subpart D: Physical Medicine Prosthetic Devices
890.3640 - Arm sling.
(a) Identification. An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
(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 ? 890.9. The device is also 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, regarding general requirements concerning records and ? 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]
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