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FDA 510(k)

TRACHESTOMY & NASAL SUCTIONING KIT #-

K-Number: K830711 · 1983-05-02

Decision Date1983-05-02
Product CodeGBZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRACHESTOMY & NASAL SUCTIONING KIT #- is the device name listed in this FDA 510(k) record. The listed applicant is Intertex Medical. It received FDA 510(k) clearance on 1983-05-02 under 510(k) number K830711. The device is classified under product code GBZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHESTOMY & NASAL SUCTIONING KIT #-?

TRACHESTOMY & NASAL SUCTIONING KIT #- is a medical device that received FDA 510(k) clearance on 1983-05-02. The listed applicant is Intertex Medical. The 510(k) number is K830711.

When did TRACHESTOMY & NASAL SUCTIONING KIT #- receive FDA 510(k) clearance?

TRACHESTOMY & NASAL SUCTIONING KIT #- received FDA 510(k) clearance on 1983-05-02, under 510(k) number K830711.

Who is the listed applicant for TRACHESTOMY & NASAL SUCTIONING KIT #-?

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

What is the FDA product code for TRACHESTOMY & NASAL SUCTIONING KIT #-?

The FDA product code for TRACHESTOMY & NASAL SUCTIONING KIT #- is GBZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: GBZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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