FDA 510(k)

FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE

K-Number: K792035 · 1979-10-26

Decision Date1979-10-26

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1979-10-26 under 510(k) number K792035. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE?

FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE is a medical device that received FDA 510(k) clearance on 1979-10-26. The listed applicant is Bivona Medical Technologies. The 510(k) number is K792035.

When did FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE receive FDA 510(k) clearance?

FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE received FDA 510(k) clearance on 1979-10-26, under 510(k) number K792035.

Who is the listed applicant for FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE?

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

What is the FDA product code for FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE?

The FDA product code for FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE is BTR.

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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.