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FDA 510(k)

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro

K-Number: K193573 · 2020-04-10

ApplicantMolnlycke Health Care Us, LLC
Decision Date2020-04-10
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro is a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2020-04-10 under approval number K193573. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro?

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro is a medical device that received FDA 510(k) clearance on 2020-04-10. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K193573.

When was Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro approved by the FDA?

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro received FDA 510(k) clearance on 2020-04-10, under approval number K193573.

What company makes Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro?

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro is manufactured by Molnlycke Health Care Us, LLC.

What is the FDA product code for Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro?

The FDA product code for Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro is KGO.

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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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