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FDA 510(k)

CORRUGATED FLEXIBLE POLYETHYLENE & EVA

K-Number: K791821 · 1979-09-26

ApplicantAirlife, Inc.
Decision Date1979-09-26
Product CodeBYX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CORRUGATED FLEXIBLE POLYETHYLENE & EVA is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1979-09-26 under 510(k) number K791821. The device is classified under product code BYX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORRUGATED FLEXIBLE POLYETHYLENE & EVA?

CORRUGATED FLEXIBLE POLYETHYLENE & EVA is a medical device that received FDA 510(k) clearance on 1979-09-26. The listed applicant is Airlife, Inc.. The 510(k) number is K791821.

When did CORRUGATED FLEXIBLE POLYETHYLENE & EVA receive FDA 510(k) clearance?

CORRUGATED FLEXIBLE POLYETHYLENE & EVA received FDA 510(k) clearance on 1979-09-26, under 510(k) number K791821.

Who is the listed applicant for CORRUGATED FLEXIBLE POLYETHYLENE & EVA?

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

What is the FDA product code for CORRUGATED FLEXIBLE POLYETHYLENE & EVA?

The FDA product code for CORRUGATED FLEXIBLE POLYETHYLENE & EVA is BYX.

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.

Other records listing Airlife, 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.

View all 76 devices →

Related Devices (Code: BYX)

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.

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.

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