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Electronic Code of Federal Regulations

e-CFR Data is current as of October 23, 2014

Title 21Chapter ISubchapter HPart 890Subpart D → §890.3520


Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart D—Physical Medicine Prosthetic Devices


§890.3520   Plinth.

(a) Identification. A plinth is a flat, padded board with legs that is intended for medical purposes. A patient is placed on the device for treatment or examination.

(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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