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Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed

FDA product code NLN · 1 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.4310
Review panel
NE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2004-11-23 – 2004-11-23

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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