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Catheter, Biliary, Reprocessed

FDA product code NML · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5010
Review panel
GU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2002-04-29 – 2002-04-29

same as "FGE" except being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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