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FDA 510(k)

GM501 Wash with Phenol Red and Gentamicin

K-Number: K192503 · 2020-11-19

ApplicantHamilton Thorne Incorporated
Decision Date2020-11-19
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GM501 Wash with Phenol Red and Gentamicin is a medical device manufactured by Hamilton Thorne Incorporated. It received FDA 510(k) clearance on 2020-11-19 under approval number K192503. 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 Wash with Phenol Red and Gentamicin?

GM501 Wash with Phenol Red and Gentamicin is a medical device that received FDA 510(k) clearance on 2020-11-19. It is manufactured by Hamilton Thorne Incorporated. The 510(k) number is K192503.

When was GM501 Wash with Phenol Red and Gentamicin approved by the FDA?

GM501 Wash with Phenol Red and Gentamicin received FDA 510(k) clearance on 2020-11-19, under approval number K192503.

What company makes GM501 Wash with Phenol Red and Gentamicin?

GM501 Wash with Phenol Red and Gentamicin is manufactured by Hamilton Thorne Incorporated.

What is the FDA product code for GM501 Wash with Phenol Red and Gentamicin?

The FDA product code for GM501 Wash with Phenol Red and Gentamicin is MQL.

Other Devices by Hamilton Thorne Incorporated

K192644GM501 SpermAir and GM501 SpermActive

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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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