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FDA 510(k)

PLEUR-EVAC A-4005 SYSTEM

K-Number: K823037 · 1982-10-28

ApplicantHowmedica Corp.
Decision Date1982-10-28
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC A-4005 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1982-10-28 under 510(k) number K823037. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEUR-EVAC A-4005 SYSTEM?

PLEUR-EVAC A-4005 SYSTEM is a medical device that received FDA 510(k) clearance on 1982-10-28. The listed applicant is Howmedica Corp.. The 510(k) number is K823037.

When did PLEUR-EVAC A-4005 SYSTEM receive FDA 510(k) clearance?

PLEUR-EVAC A-4005 SYSTEM received FDA 510(k) clearance on 1982-10-28, under 510(k) number K823037.

Who is the listed applicant for PLEUR-EVAC A-4005 SYSTEM?

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

What is the FDA product code for PLEUR-EVAC A-4005 SYSTEM?

The FDA product code for PLEUR-EVAC A-4005 SYSTEM is GCX.

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Other records listing Howmedica Corp. as applicant

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Related Devices (Code: GCX)

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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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