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e-CFR data is current as of December 1, 2020

Title 21Chapter ISubchapter HPart 878Subpart E → §878.4160


Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices


§878.4160   Surgical camera and accessories.

(a) Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.

(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 §878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 66 FR 38802, July 25, 2001]

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