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Title 21 Part 880 → Subpart G → §880.6230

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6230

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6230

e-CFR data is current as of July 17, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6230


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§880.6230   Tongue depressor.

(a) Identification. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

(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 §880.9. If the device is not labeled or otherwise represented as sterile, it 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, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]