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FDA 510(k)

Avance Tubing, Avance Y-Connector, Avance ViewPad

K-Number: K161797 · 2016-10-19

Decision Date2016-10-19
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Avance Tubing, Avance Y-Connector, Avance ViewPad is a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-10-19 under approval number K161797. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avance Tubing, Avance Y-Connector, Avance ViewPad?

Avance Tubing, Avance Y-Connector, Avance ViewPad is a medical device that received FDA 510(k) clearance on 2016-10-19. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K161797.

When was Avance Tubing, Avance Y-Connector, Avance ViewPad approved by the FDA?

Avance Tubing, Avance Y-Connector, Avance ViewPad received FDA 510(k) clearance on 2016-10-19, under approval number K161797.

What company makes Avance Tubing, Avance Y-Connector, Avance ViewPad?

Avance Tubing, Avance Y-Connector, Avance ViewPad is manufactured by Molnlycke Health Care Us, LLC.

What is the FDA product code for Avance Tubing, Avance Y-Connector, Avance ViewPad?

The FDA product code for Avance Tubing, Avance Y-Connector, Avance ViewPad is OMP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.