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System, Surgical, Computer Controlled Instrument, Remanufactured

FDA product code QSM · 8 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1500
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-09-30 – 2026-03-26

As intended with the originally cleared instrument.

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