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FDA 510(k)

CLEARADEX GEL

K-Number: K060561 · 2006-05-30

ApplicantCambridgemed
Decision Date2006-05-30
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CLEARADEX GEL is the device name listed in this FDA 510(k) record. The listed applicant is Cambridgemed. It received FDA 510(k) clearance on 2006-05-30 under 510(k) number K060561. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARADEX GEL?

CLEARADEX GEL is a medical device that received FDA 510(k) clearance on 2006-05-30. The listed applicant is Cambridgemed. The 510(k) number is K060561.

When did CLEARADEX GEL receive FDA 510(k) clearance?

CLEARADEX GEL received FDA 510(k) clearance on 2006-05-30, under 510(k) number K060561.

Who is the listed applicant for CLEARADEX GEL?

The FDA 510(k) record lists Cambridgemed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARADEX GEL?

The FDA product code for CLEARADEX GEL is KHJ.

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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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