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Mediastinoscope, Surgical

FDA product code EWY · 10 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.4720
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1991-10-24 – 2026-03-02

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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