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FDA 510(k)

HEP-TROL

K-Number: K801932 · 1980-09-09

ApplicantHelena Laboratories
Decision Date1980-09-09
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEP-TROL is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801932. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEP-TROL?

HEP-TROL is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Helena Laboratories. The 510(k) number is K801932.

When did HEP-TROL receive FDA 510(k) clearance?

HEP-TROL received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801932.

Who is the listed applicant for HEP-TROL?

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 HEP-TROL?

The FDA product code for HEP-TROL is GGW.

Other records listing Helena Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GGW)

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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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