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Staple, Implantable, Reprocessed

FDA product code NLL · 3 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4750
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-07-11 – 2007-10-18

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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