FDA 510(k)

MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE

K-Number: K896547 · 1990-01-22

Decision Date1990-01-22

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE 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 1990-01-22 under 510(k) number K896547. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE?

MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Bivona Medical Technologies. The 510(k) number is K896547.

When did MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE receive FDA 510(k) clearance?

MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE received FDA 510(k) clearance on 1990-01-22, under 510(k) number K896547.

Who is the listed applicant for MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE?

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 MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE?

The FDA product code for MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE is JOH.

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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.