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FDA 510(k)

PuraStat-OM

K-Number: K210211 · 2021-10-08

Applicant3-D Matrix, Inc.
Decision Date2021-10-08
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

PuraStat-OM is a medical device manufactured by 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2021-10-08 under approval number K210211. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PuraStat-OM?

PuraStat-OM is a medical device that received FDA 510(k) clearance on 2021-10-08. It is manufactured by 3-D Matrix, Inc.. The 510(k) number is K210211.

When was PuraStat-OM approved by the FDA?

PuraStat-OM received FDA 510(k) clearance on 2021-10-08, under approval number K210211.

What company makes PuraStat-OM?

PuraStat-OM is manufactured by 3-D Matrix, Inc..

What is the FDA product code for PuraStat-OM?

The FDA product code for PuraStat-OM is OLR.

Other Devices by 3-D Matrix, Inc.

K183015PuraSinus K193085PuraDERM Gel K210098PuraStat-GI K213552PuraStat-RM K222481PuraStat

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Official Source

View on FDA Database →

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

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