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FDA 510(k)

CASCADE 480

K-Number: K921363 · 1992-06-09

ApplicantHelena Laboratories
Decision Date1992-06-09
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CASCADE 480 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K921363. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASCADE 480?

CASCADE 480 is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is Helena Laboratories. The 510(k) number is K921363.

When did CASCADE 480 receive FDA 510(k) clearance?

CASCADE 480 received FDA 510(k) clearance on 1992-06-09, under 510(k) number K921363.

Who is the listed applicant for CASCADE 480?

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 CASCADE 480?

The FDA product code for CASCADE 480 is GKP.

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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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