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FDA 510(k)

VIRAGARD/VIRASHIELD

K-Number: K820459 · 1982-06-16

ApplicantTri-Med, Inc.
Decision Date1982-06-16
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIRAGARD/VIRASHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Med, Inc.. It received FDA 510(k) clearance on 1982-06-16 under 510(k) number K820459. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRAGARD/VIRASHIELD?

VIRAGARD/VIRASHIELD is a medical device that received FDA 510(k) clearance on 1982-06-16. The listed applicant is Tri-Med, Inc.. The 510(k) number is K820459.

When did VIRAGARD/VIRASHIELD receive FDA 510(k) clearance?

VIRAGARD/VIRASHIELD received FDA 510(k) clearance on 1982-06-16, under 510(k) number K820459.

Who is the listed applicant for VIRAGARD/VIRASHIELD?

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

What is the FDA product code for VIRAGARD/VIRASHIELD?

The FDA product code for VIRAGARD/VIRASHIELD is DRS.

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Other records listing Tri-Med, Inc. as applicant

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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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