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FDA 510(k)

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6

K-Number: K190663 · 2019-06-17

Decision Date2019-06-17
Product CodeBSN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2019-06-17 under approval number K190663. The device is classified under product code BSN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6?

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 is a medical device that received FDA 510(k) clearance on 2019-06-17. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K190663.

When was Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 approved by the FDA?

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 received FDA 510(k) clearance on 2019-06-17, under approval number K190663.

What company makes Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6?

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 is manufactured by PAJUNK GmbH Medizintechnologie.

What is the FDA product code for Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6?

The FDA product code for Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 is BSN.

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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.