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Code · CFR · Title 21 — Food and Drugs · Part 870 — Cardiovascular Devices · § 870.4500

§ 870.4500. Cardiovascular surgical instruments.

77 words·~1 min read·/us/cfr/t21/s§ 870.4500·

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(a)Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.
(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 § 870.9. [45 FR 7907, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 FR 38797, July 25, 2001]
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§ 870.4500
Cardiovascular surgical instruments.
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