FDA 510(k)

SHILEY FLEXTRA TRACHEOSTOMY TUBE

K-Number: K030787 · 2003-11-14

Decision Date2003-11-14

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SHILEY FLEXTRA TRACHEOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 2003-11-14 under 510(k) number K030787. 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 SHILEY FLEXTRA TRACHEOSTOMY TUBE?

SHILEY FLEXTRA TRACHEOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 2003-11-14. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K030787.

When did SHILEY FLEXTRA TRACHEOSTOMY TUBE receive FDA 510(k) clearance?

SHILEY FLEXTRA TRACHEOSTOMY TUBE received FDA 510(k) clearance on 2003-11-14, under 510(k) number K030787.

Who is the listed applicant for SHILEY FLEXTRA TRACHEOSTOMY TUBE?

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

What is the FDA product code for SHILEY FLEXTRA TRACHEOSTOMY TUBE?

The FDA product code for SHILEY FLEXTRA TRACHEOSTOMY TUBE is JOH.

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Related Devices (Code: 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.