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FDA 510(k)

Polyform Synthetic Mesh

K-Number: K171271 · 2017-12-15

ApplicantBoston Scientific Corporation
Decision Date2017-12-15
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Polyform Synthetic Mesh is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-12-15 under approval number K171271. The device is classified under product code OTO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polyform Synthetic Mesh?

Polyform Synthetic Mesh is a medical device that received FDA 510(k) clearance on 2017-12-15. It is manufactured by Boston Scientific Corporation. The 510(k) number is K171271.

When was Polyform Synthetic Mesh approved by the FDA?

Polyform Synthetic Mesh received FDA 510(k) clearance on 2017-12-15, under approval number K171271.

What company makes Polyform Synthetic Mesh?

Polyform Synthetic Mesh is manufactured by Boston Scientific Corporation.

What is the FDA product code for Polyform Synthetic Mesh?

The FDA product code for Polyform Synthetic Mesh is OTO.

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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.

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