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FDA 510(k)

R3 Anteverted Liners

K-Number: K182535 · 2018-11-19

Decision Date2018-11-19
Product CodeMBL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

R3 Anteverted Liners is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2018-11-19 under approval number K182535. The device is classified under product code MBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R3 Anteverted Liners?

R3 Anteverted Liners is a medical device that received FDA 510(k) clearance on 2018-11-19. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K182535.

When was R3 Anteverted Liners approved by the FDA?

R3 Anteverted Liners received FDA 510(k) clearance on 2018-11-19, under approval number K182535.

What company makes R3 Anteverted Liners?

R3 Anteverted Liners is manufactured by Smith & Nephew, Inc..

What is the FDA product code for R3 Anteverted Liners?

The FDA product code for R3 Anteverted Liners is MBL.

Other Devices by Smith & Nephew, Inc.

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Related Devices (Code: MBL)

Official Source

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