FDA 510(k)

TRACHEOSTOMY CARE KIT (STERILE)

K-Number: K925020 · 1993-07-07

Decision Date1993-07-07

Product CodeJOH

Advisory CommitteeAN

DecisionUnknown

Device Summary

TRACHEOSTOMY CARE KIT (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1993-07-07 under 510(k) number K925020. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TRACHEOSTOMY CARE KIT (STERILE)?

TRACHEOSTOMY CARE KIT (STERILE) is a medical device that received FDA 510(k) clearance on 1993-07-07. The listed applicant is Customed, Inc.. The 510(k) number is K925020.

When did TRACHEOSTOMY CARE KIT (STERILE) receive FDA 510(k) clearance?

TRACHEOSTOMY CARE KIT (STERILE) received FDA 510(k) clearance on 1993-07-07, under 510(k) number K925020.

Who is the listed applicant for TRACHEOSTOMY CARE KIT (STERILE)?

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

What is the FDA product code for TRACHEOSTOMY CARE KIT (STERILE)?

The FDA product code for TRACHEOSTOMY CARE KIT (STERILE) is JOH.

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Other records listing Customed, Inc. as applicant

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277 K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K962596CUSTOMED BLOOD EXTRACTION KIT K961442UNIVERSAL DRAINAGE TRAY

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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.