Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart E - Surgical Devices / § 888.4600 Protractor for clinical use.
§ 888.4600 Protractor for clinical use.
(a) Identification. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.
(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 § 888.9.