FDA 510(k)

RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE

K-Number: K955564 · 1996-06-28

Decision Date1996-06-28

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Rusch, Inc.. It received FDA 510(k) clearance on 1996-06-28 under 510(k) number K955564. 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 RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE?

RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE is a medical device that received FDA 510(k) clearance on 1996-06-28. The listed applicant is Rusch, Inc.. The 510(k) number is K955564.

When did RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE receive FDA 510(k) clearance?

RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE received FDA 510(k) clearance on 1996-06-28, under 510(k) number K955564.

Who is the listed applicant for RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE?

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

What is the FDA product code for RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE?

The FDA product code for RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE 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.