|
Device |
choledochoscope and accessories, flexible/rigid |
Regulation Description |
Endoscope and accessories. |
Definition |
to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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). |
Product Code | FBN |
Regulation Number |
876.1500
|
Device Class |
2
|
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