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FDA 510(k)

MODIFICATION COLUMNMATE

K-Number: K920820 · 1992-08-17

ApplicantHelena Laboratories
Decision Date1992-08-17
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION COLUMNMATE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1992-08-17 under 510(k) number K920820. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION COLUMNMATE?

MODIFICATION COLUMNMATE is a medical device that received FDA 510(k) clearance on 1992-08-17. The listed applicant is Helena Laboratories. The 510(k) number is K920820.

When did MODIFICATION COLUMNMATE receive FDA 510(k) clearance?

MODIFICATION COLUMNMATE received FDA 510(k) clearance on 1992-08-17, under 510(k) number K920820.

Who is the listed applicant for MODIFICATION COLUMNMATE?

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

What is the FDA product code for MODIFICATION COLUMNMATE?

The FDA product code for MODIFICATION COLUMNMATE is LCP.

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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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