FDA 510(k)

VILENE SURGICAL MASK 5505

K-Number: K840090 · 1984-04-25

Decision Date1984-04-25

Product Code

DecisionSubstantially Equivalent

Device Summary

VILENE SURGICAL MASK 5505 is the device name listed in this FDA 510(k) record. The listed applicant is Hall-Tech. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K840090. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VILENE SURGICAL MASK 5505?

VILENE SURGICAL MASK 5505 is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Hall-Tech. The 510(k) number is K840090.

When did VILENE SURGICAL MASK 5505 receive FDA 510(k) clearance?

VILENE SURGICAL MASK 5505 received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840090.

Who is the listed applicant for VILENE SURGICAL MASK 5505?

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

Related Clinical Trials

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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Other records listing Hall-Tech as applicant

K831917VILENE COTTON GAUZE II

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.