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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 F: Physical Medicine Therapeutic Devices
890.5710 - Hot or cold disposable pack.
(a) Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
(b) Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to ? 890.9.
[48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]
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