FDA 510(k)

GM501 Mineral Oil

K-Number: K191552 · 2019-09-18

Decision Date2019-09-18

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GM501 Mineral Oil is a medical device manufactured by Hamilton Thorne, Inc.. It received FDA 510(k) clearance on 2019-09-18 under approval number K191552. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GM501 Mineral Oil?

GM501 Mineral Oil is a medical device that received FDA 510(k) clearance on 2019-09-18. It is manufactured by Hamilton Thorne, Inc.. The 510(k) number is K191552.

When was GM501 Mineral Oil approved by the FDA?

GM501 Mineral Oil received FDA 510(k) clearance on 2019-09-18, under approval number K191552.

What company makes GM501 Mineral Oil?

GM501 Mineral Oil is manufactured by Hamilton Thorne, Inc..

What is the FDA product code for GM501 Mineral Oil?

The FDA product code for GM501 Mineral Oil is MQL.

Other Devices by Hamilton Thorne, Inc.

K190383GM501 Wash K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

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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.