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Code · CFR · Title 21 — Food and Drugs · Part 888 — Orthopedic Devices · § 888.4800

§ 888.4800. Template for clinical use.

82 words·~1 min read·/us/cfr/t21/s§ 888.4800·

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(a)Identification. A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
(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. [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]
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§ 888.4800
Template for clinical use.
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