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FDA 510(k)

Pakter Curved Needle Set

K-Number: K173155 · 2018-06-07

Decision Date2018-06-07
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pakter Curved Needle Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-06-07 under approval number K173155. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pakter Curved Needle Set?

Pakter Curved Needle Set is a medical device that received FDA 510(k) clearance on 2018-06-07. It is manufactured by Cook Incorporated. The 510(k) number is K173155.

When was Pakter Curved Needle Set approved by the FDA?

Pakter Curved Needle Set received FDA 510(k) clearance on 2018-06-07, under approval number K173155.

What company makes Pakter Curved Needle Set?

Pakter Curved Needle Set is manufactured by Cook Incorporated.

What is the FDA product code for Pakter Curved Needle Set?

The FDA product code for Pakter Curved Needle Set is BSP.

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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.