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FDA 510(k)

ECA GEL PROUDUCT REFORMULATION

K-Number: K802647 · 1981-01-08

ApplicantVanaray Laboratories, Inc.
Decision Date1981-01-08
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ECA GEL PROUDUCT REFORMULATION is the device name listed in this FDA 510(k) record. The listed applicant is Vanaray Laboratories, Inc.. It received FDA 510(k) clearance on 1981-01-08 under 510(k) number K802647. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECA GEL PROUDUCT REFORMULATION?

ECA GEL PROUDUCT REFORMULATION is a medical device that received FDA 510(k) clearance on 1981-01-08. The listed applicant is Vanaray Laboratories, Inc.. The 510(k) number is K802647.

When did ECA GEL PROUDUCT REFORMULATION receive FDA 510(k) clearance?

ECA GEL PROUDUCT REFORMULATION received FDA 510(k) clearance on 1981-01-08, under 510(k) number K802647.

Who is the listed applicant for ECA GEL PROUDUCT REFORMULATION?

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

What is the FDA product code for ECA GEL PROUDUCT REFORMULATION?

The FDA product code for ECA GEL PROUDUCT REFORMULATION is GYB.

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Other records listing Vanaray Laboratories, Inc. 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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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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